Micro Needling Stretch Marks Part - I

The Dermapen microneedling device provides an unparalleled response via the fractional delivery of micro-needles, creating micro-injuries to the epidermis and dermis. These micro-injuries to the skin encourage and harness the power of the body’s innate ability to repair the skin through the normal physiology of skin. The first phase begins with the release of the bodies growth factors and the further cascade of new epidermal growth, fibroblast chemotaxis, fibroblast proliferation and matrix production. This proliferation of the body’s tissue continues to release growth factors from fibroblasts, keratinocytes and monocytes. The second phase of wound healing involves deposition of collagen III, IV and I, elastin, proteoglycans, and GAGs. The last phase results in tissue remodeling where the skins vascular matrix matures and skin tightening. The body’s ability to heal itself is at the heart of this amazing process.

What makes Dermapen Different:

The closest technology to the Dermapen is a fractional laser. A fractional laser “drills holes” in the skin to create a wound healing response and leaves normal tissue around the holes to be a reservoir for fibroblasts and stem cells to migrate into the holes. Fractional radiofrequency devices work on a similar principle and have many of the same side effects as fractional lasers (Yeung et al., 2012). Dermapen also makes holes in the skin to create a wound healing response and leaves normal tissue around the holes. These technologies have similar results, but achieve them in very different ways, and result in very different side effects profiles. The laser uses light to char and obliterate epidermis to produce small pits which vary in diameter and depth, depending on the laser type (Erbium, YAG, CO2; nonablative vs ablative) and manufacturer. Dermapen produces reproducible and consistent holes in the skin.

Side effects differ between technologies. Most fractional lasers leave erythema and edema up to 96 hours after treatment. Resultant downtime is approximately 3-4 days for fractional laser treatments (Gold, 2010). Dermapen treatments result in erythema with slight chance of edema for about 24 hours. Common side effects of fractional lasers are:

Pain (higher in dark skined patients (Mahmoud et al., 2010)

Persistent erythema (Gold 2010)

Infections (viral and bacterial). Facial herpes reported in 10.6% of patients in spite of antiviral prophylaxis (Naouri et al., 2011)

Post inflammatory hyperpigmentation in up to 18% (Vaiyavatjamai and Wattanakrai, 2011; Chan et al., 2010; Mahmoud et al., 2010; Yeung et al., 2012)

Postinflammatory hypopigmentation – seen in patients up to two years after a laser treatment. Occurs in up to 20% of patients with photo-aged skin (Gold 2001).

Light based therapy is not for all skin types. For example, the indications for use cleared by the FDA may put limits on the skin types that may be treated with a fractional laser. For example, the indications for use may prohibit the use of the laser on Fitzpatrick 4, 5 , and 6 (darker skin colors), for example: “The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.” K090639. The fractional holes “drilled” by the laser are a function of skin type, skin thickness, and vascularity. Dermapen does not rely on skin color to turn light into heat.

A major complication from light based therapy includes Postinflamatory Hyperpigmentation (PIH) in Oriental, Mediterranean, and African skin types (Yeung et al., 2012; Metelitsa and Alster 2010; Chan et al., 2007). PIH presents as symmetric hyperpigmented macules and patches on the face. PIH is one of the most common and distressing pigmentary disorders seen in dermatology clinics. It is notably difficult to treat and may relapse.

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Micro Needling Pen Benefit

The Dermapen® microneedling device provides an unparalleled response via the fractional delivery of micro-needles, creating micro-injuries to the epidermis and dermis. These micro-injuries to the skin encourage and harness the power of the body’s innate ability to repair the skin through the normal physiology of skin.

Every cartridge has multiple needles, with proprietary technology, penetrating vertically generating small micro skin channels, while stimulating the natural production of collagen. These channels carry up to 80% more topical nutrients, allowing penetration deep to the skin fibroblasts, feeding the cells found in the dermis and the basal layer.

The Dermapen® is so advanced, it is appropriate and recommended to use in sensitive and previously inaccessible areas such as the upper and lower eyes, lips and nose.

Dermapen® Microneedling Technology is the leader in safety and innovation.

The Dermapen® uses sterile, sealed individual and disposable needle cartridges for optimal patient safety. Every cartridge has multiple needles, with proprietary technology, penetrating vertically generating small micro skin channels, while stimulating the natural production of collagen.

These channels carry up to 80% more topical nutrients, allowing penetration deep to the skin fibroblasts, feeding the cells found in the dermis and the basal layer. This increases the absorption of active ingredients into the skin, stimulating the repair at a cellular level and accelerating the regeneration of the skin’s epidermal cells.

The treatment is similar to laser treatments, but without the severe side effects or the long recovery time. There are some studies that show it is more effective than traditional microdermabrasion and chemical peels. The disposable needles reduces the risk of cross-contamination and the adjustable depth allows treatment that is adaptable to individual needs.

MICRONEEDLING ACNE SCARS WITH DERMAPEN®

Scars are areas of fibrous tissue (fibrosis) that replace normal skin after injury. A scar results from the biological process of wound repair in the skin and other tissues of the body. With the exception of very minor lesions, every wound (e.g. after accident, disease, surgery) results in some degree of scarring. Scar tissue is the same protein (collagen) as the tissue that it replaces, but the fiber composition of the protein is different. Instead of a nice “basket weave” formation of fibers, the collagen in scar tissue is aligned in a single direction resulting in a pronounced and thicker appearance. Acne treatments for most are long term and can result in scarring. There are multiple causes of acne including hormone dysfunction, allergies, environmental factors and nutrition deficiencies. Acne scars result after skin follicles become blocked by excessive oils and the physiology of keratin and old skin cells trigger an inflammatory response reaction. The skin will attempt to heal and the scar tissue results as the collagen becomes deformed and thickens. Acne scars are categorized as being “ice- pick”, “rolling” or “boxcar

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Micro Needling For Scar Removal

Stene Brian Marshall – Rewards Paid For Information

UPDATE The FDA is looking for current addresses on the following business in the USA: 

DermapenUSADermapenWorldDermapen, LLC is looking for current addresses and any information on the following: Artland Holdings CNS Assets Proprietary Fleming Trust Equipmed International BioSoftStene Brian Marshall Corri Marshall Brian Marshall Cornelia Marshall Joel Marshall Sasha Marshall Victor Azrak Randy Wright (CEO) Geoff Graham (VP of Sales) Matthew Lloyd (CFO) ArtiMoussaKeliCypriano Robin Cypriano Michelle Boehle (California Area Rep) Brian Alberston Andrew R. Christie Kelly Wallace Rewards paid for other material, physical addresses, aliases, litigation, debts, real property, attorneys, blood relatives, business partners, receivers, auditors, co-conspirators, alleged co-conspirators, co-owners, trustees, shells, other people, entities, trusts, corporations, partnerships, LLCs, data providers, hosting companies, locations of data stores or data backups, cloud accounts, cloud storage, any related banking or merchant account used by any of these entities to clear sales transactions for Equipmed, Biosoft, DermapenUSA, DermapenWorld, 4EverYoung, The Fleming Family Trust, CNS Assets Proprietary, Shaun Kerrigan, any of the Marshalls, etc. DermapenWorld and DermapenUSA known addresses are as follows, but appear to be vacant: DermapenWorld 915 Middle River Drive Suite 160 Fort Lauderdale, FL 33304 Dermapen USA 401 Highway 74 N Peachtree City, Georgia 30269 We will be posting a graphic of all relationships at www.Dermapen.com/Stene-Marshall shortly. Please email any information privately to mike@dermagenusa.com

My name is Angie Nickell and skin care has been my passion since 1989 after experiencing grade 4 acne from the age of ten until way into my fifties, I wanted to help others. Now many years later, I can now offer my patients great new treatments and modalities that will keep you looking wonderful for your age. From my Signature Facial to Medical Grade Micro-Needling the treatments are vast and specfic for your needs. With a focus on your concerns, I will customize a program of treatments and homecare that will address your skin concerns from acne to severe sun damage and aged skin. As long as you are breathing, we can make a difference, age is just a number”.

“I have been involved in every aspect of this amazing and ever changing industry from the spa setting to the operating room, having experienced four years in the field of plastic surgery, preforming all pre and post-op care treatments. Today I value a quiet setting at Ormond Medical Center by appointment seeing one patient at a time targeting their needs while providing a sense of tranquility coupled with guaranteed results”.

“We are so excited to offer Dermapen Micro-needling at our clinic. Patients love the results, the minimal downtime and the near painless procedure. For anyone looking to stimulate collagen or improve scars or stretchmarks, Dermapen is a great solution”.

For more details on our products and services, please feel free to visit us at micro needling for scars, micro needling benefits & micro needling eyebrows

Micro Needling Eyebrows Near Me

Enter the MDerma Pen Technology

The MDerma™ uses sterile, sealed individual and disposable needle cartridges for optimal patient safety. Every cartridge has multiple needles, with proprietary technology, penetrating vertically generating small micro skin channels, while stimulating the natural production of collagen. These channels carry up to 80% more topical nutrients, allowing penetration deep to the skin fibroblasts, feeding the cells found in the dermis and the basal layer. This increases the absorption of active ingredients into the skin, stimulating the repair at a cellular level and accelerating the regeneration of the skin’s epidermal cells.

The treatment is similar to laser treatments, but without the severe side effects or the long recovery time. There are some studies that show it is more effective than traditional microdermabrasion and chemical peels. The disposable needles reduces the risk of cross-contamination and the adjustable depth allows treatment that is adaptable to individual needs.

MDerma™ is so advanced, it is appropriate and recommended to use in sensitive and previously inaccessible areas such as the upper and lower eyes, lips and nose.

"I have been utilizing the Dermapen in my practice over the last two years. Recently I was able to try the new tip with the scalloped edge. Wow! Words cannot express how happy I was with the new tip. The scalloped tip glides easily over the skin with no dragging or catching. This tip by far exceeds my expectations! With this new improved tip the treatment is much more enjoyable for the patient! Great work Dermapen!" - Trina Nesselrotte,LE,CMLT

Stene Brian Marshall – Rewards Paid For Information

UPDATE The FDA is looking for current addresses on the following business in the USA: DermapenUSADermapenWorldDermapen, LLC is looking for current addresses and any information on the following: Artland Holdings CNS Assets Proprietary Fleming Trust Equipmed International BioSoftStene Brian Marshall Corri Marshall Brian Marshall Cornelia Marshall Joel Marshall Sasha Marshall Victor Azrak Randy Wright (CEO) Geoff Graham (VP of Sales) Matthew Lloyd (CFO) ArtiMoussaKeliCypriano Robin Cypriano Michelle Boehle (California Area Rep) Brian Alberston Andrew R. Christie Kelly Wallace Rewards paid for other material, physical addresses, aliases, litigation, debts, real property, attorneys, blood relatives, business partners, receivers, auditors, co-conspirators, alleged co-conspirators, co-owners, trustees, shells, other people, entities, trusts, corporations, partnerships, LLCs, data providers, hosting companies, locations of data stores or data backups, cloud accounts, cloud storage, any related banking or merchant account used by any of these entities to clear sales transactions for Equipmed, Biosoft, DermapenUSA, DermapenWorld, 4EverYoung, The Fleming Family Trust, CNS Assets Proprietary, Shaun Kerrigan, any of the Marshalls, etc. DermapenWorld and DermapenUSA known addresses are as follows, but appear to be vacant: DermapenWorld 915 Middle River Drive Suite 160 Fort Lauderdale, FL 33304 Dermapen USA 401 Highway 74 N Peachtree City, Georgia 30269 We will be posting a graphic of all relationships at www.Dermapen.com/Stene-Marshall shortly. Please email any information privately to mike@dermagenusa.com

For more details on our products and services, please feel free to visit us at micro needling for scars, micro needling benefits & micro needling eyebrows

Micro Needling Pen Side Effects

Dermapen uses multiple needles that vertically pierce the skin. This enhances rejuvenation results and is far safer for the client because there is much less epidermal damage.

The automatic vibrating function of the Dermapen increases the effectiveness of treatment by increasing absorption of products, while reducing pain and discomfort.

Dermapen is just as effective as ablative treatments such as Fraxel, IPL, Laser Resurfacing, and Chemical Peels. The most amazing benefit is that Dermapen's pricing is a fraction of the leading alternatives.

Enter the MDerma Pen Technology

The MDerma™ uses sterile, sealed individual and disposable needle cartridges for optimal patient safety. Every cartridge has multiple needles, with proprietary technology, penetrating vertically generating small micro skin channels, while stimulating the natural production of collagen. These channels carry up to 80% more topical nutrients, allowing penetration deep to the skin fibroblasts, feeding the cells found in the dermis and the basal layer. This increases the absorption of active ingredients into the skin, stimulating the repair at a cellular level and accelerating the regeneration of the skin’s epidermal cells.

The treatment is similar to laser treatments, but without the severe side effects or the long recovery time. There are some studies that show it is more effective than traditional microdermabrasion and chemical peels. The disposable needles reduces the risk of cross-contamination and the adjustable depth allows treatment that is adaptable to individual needs. MDerma™ is so advanced, it is appropriate and recommended to use in sensitive and previously inaccessible areas such as the upper and lower eyes, lips and nose.

Stene Brian Marshall – Rewards Paid For Information

UPDATE The FDA is looking for current addresses on the following business in the USA: 

DermapenUSADermapenWorld Dermapen, LLC is looking for current addresses and any information on the following: Artland Holdings CNS Assets Proprietary Fleming Trust Equipmed International BioSoftStene Brian Marshall Corri Marshall Brian Marshall Cornelia Marshall Joel Marshall Sasha Marshall Victor Azrak Randy Wright (CEO) Geoff Graham (VP of Sales) Matthew Lloyd (CFO) ArtiMoussaKeliCypriano Robin Cypriano Michelle Boehle (California Area Rep) Brian Alberston Andrew R. Christie Kelly Wallace Rewards paid for other material, physical addresses, aliases, litigation, debts, real property, attorneys, blood relatives, business partners, receivers, auditors, co-conspirators, alleged co-conspirators, co-owners, trustees, shells, other people, entities, trusts, corporations, partnerships, LLCs, data providers, hosting companies, locations of data stores or data backups, cloud accounts, cloud storage, any related banking or merchant account used by any of these entities to clear sales transactions for Equipmed, Biosoft, DermapenUSA, DermapenWorld, 4EverYoung, The Fleming Family Trust, CNS Assets Proprietary, Shaun Kerrigan, any of the Marshalls, etc. DermapenWorld and DermapenUSA known addresses are as follows, but appear to be vacant: DermapenWorld 915 Middle River Drive Suite 160 Fort Lauderdale, FL 33304 Dermapen USA 401 Highway 74 N Peachtree City, Georgia 30269 We will be posting a graphic of all relationships at www.Dermapen.com/Stene-Marshall shortly. Please email any information privately to mike@dermagenusa.com

For more details on our products and services, please feel free to visit us at micro needling for scars, micro needling benefits & micro needling side effects

Micro Needling Pen Benefits

FDA Warns – Micro-Needling devices are not exempt Class 1

Dear Practitioners, Please be advised that Derma Pen, LLC is no longer selling its micro-needling devices or micro-needling tips effective April 17, 2015. This notice is a follow-up to and clarification of the letter Derma Pen sent you on February 5th, 2015, which advised you it had received a warning letter from the FDA. The decision to cease sales is based on Derma Pen’s acceptance of the position of the Food and Drug Administration’s Compliance Division that micro-needling devices, such as the Dermapen, require a different method of registration than the industry has been using up to this point. Specifically, in the warning letter of January 9, 2015, the FDA stated that under 21 CFR § 878.4820, powered dermabrasion devices “have abrasion substrates which are brushes, rasps and burrs that are intended to abrade and remove layers of skin via shear force.” Because the Dermapen and similar micro-needling devices use needles to penetrate the skin rather than shearing away layers of skin, a micro-needling device like the Dermapen “…exceeds the limitation of 21 CFR § 878.9 and therefore, is not exempt from premarket notification.” In other words, claims for micro-needling and the scientific technology behind micro-needling are currently outside the scope of the 21 C.F.R § 878.4820 for surgical dermabrasion devices and, therefore, the micro-needling devices are not exempt Class 1 devices. Derma Pen sent a “Response Letter” to the FDA outlining the company’s position and explained its original decision to list micro-needling under 21 C.F.R § 878.4820 and proposed several regulatory tracks under which Derma Pen believed the Dermapen could be sold. The letter also advised the FDA that the original decision was based on expert advice from a respected regulatory consulting firm. On March 30, 2015, the FDA sent Derma Pen its response in the form of a “Regulatory Meeting Request,” in which the FDA responded to the regulatory options Derma Pen provided in its letter. Most importantly, the FDA reiterated its position from the warning letter and concluded that Derma Pen’s micro-needling device “…cannot be marketed within the United States” until the devices have “obtained the appropriate premarket clearance or approval.” 

Derma Pen, LLC respectfully maintains that the original listing did have merit, was done in good faith, was compliant with applicable regulations, and was consistent with the listing of other micro-needling devices marketed in the U.S. Ultimately, however, the regulatory decision belongs to the FDA, and we respect the process as a leader in the industry. As noted in the letter Derma Pen sent to you on February 5th, 2015, the warning letter can be found

at:http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429899.htm Consequently, we have accepted the FDA’s position that the underlying scientific technology of micro-needling differs from its current registration for “dermabrasion” and therefore is not an exempt Class 1 device.

Accordingly, Derma Pen agreed to stop selling micro-needling devices and tips in the USA. 

MARKET ANALYSIS It’s only natural that the FDA would begin enforcement of its recent decision with Derma Pen because Derma Pen is an industry leader and had reached out to the FDA last year. There are, however, at least ten other companies that distribute micro-needling devices in the United States, eight of which are also using the same registration (i.e., as an exempt Class 1 device). While we have no direct information about how the FDA will respond to other companies, but it seems logical to expect the FDA to send similar warning letters to companies using micro-needling technology and that the FDA will require them to cease sales until they obtain a new classification from the FDA.DISCONTINUED SALES At this time, it appears that there is no approved regulatory manner for selling micro-needling devices in the United States other than to request a classification opinion from the FDA and to follow the regulatory steps that such an opinion would require. If that changes, we will of course let you know. But in the meantime, we regret to inform you that all pending sales of devices and tips have been canceled.

No customers will be charged for any pending product sales or orders. Similarly, Derma Pen, LLC will no longer service products or process returned products in exchange for new products. The FDA has determined that this practice would impermissible perpetuate the continued use of the micro-needling device. Likewise, Derma Pen, LLC has canceled. all plans to sell the MDerma FDS. Derma Pen is therefore canceling all existing or pending sales of the MDerma FDS in order to comply with the FDA’s decision until the proper regulatory path is granted by the FDA We are sorry for any inconvenience this may cause you. If you have customer concerns or questions please direct them to Derma Pen’s phone line at 1-800-981-5402 or email info@dermapen.com If you have questions about other micro-needling devices that are currently being sold in the USA you can contact:Matthew R. Dionne, Pharm.D., BCPS, MBA Commander U.S. PHS United States Food and Drug Administration Compliance Officer Denver District Office PO Box 25087 Denver, CO 80225 303-236-3064 Derma Pen, LLC wishes to thank you for your business and support you have shown over the past several years. Sincerely, Derma Pen, LLC Management

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Micro Needling Eyebrows

Dermapen® Tips with SURSPACE™ Technology

The newly redesigned Dermapen® disposable tips will be the first micro-needling tip to come equipped with SURSPACE™ Technology. SURSPACE™ Technology is the algorithmically calculated, equidistant spacing and positioning of the individual micro-needles from one another. The redesigned tip now comes with a total of 12 micro-needles, nine around the perimeter of the tip and the remaining three in the center. Precisely aligning the micro-needles drastically diminishes any discomfort that may be associated with micro-needling. The new tip also features a scalloped edge, which minimizes surface tension and thus shortening the amount of time needed to perform the needling session. The scalloped grooves on the needle tip face reduce suction within the tip housing decreasing epidermal damage even further. In addition to these new advancements, the updated tips incorporate two opposing vents that highly restrict the possibility of backflow of bodily fluids into the body of the handpiece, eliminating the possibility of cross-contamination.

Can I reuse the tips?

The Dermapen sterile micro-needle tips are designed to be disposable and are for a single-use only to prevent cross-contamination and infection. The micro-needling tips cannot be properly decontaminated due to the materials used in the construction of the micro-needle tip cartridge itself. Tip cartridges CANNOT be re-used, as patient safety is of paramount importance. The Dermapen’s design permits the user to change the needle tip cartridge after each Dermapen needling session. A low consumable cost, combined with little to no downtime for the patient, makes Dermapen an ideal solution for any medical spa or clinic.

Proudly designed and engineered in the USA, these features, including SURSPACE™ Technology, allow for easier perforations to soft tissue, while achieving the safest, most effective micro-needling experience. SURSPACE™ is a trademark of Dermagen International, LLC. Derma Pen, LLC is the authorized distributor of SURSPACE™ in the United States. Dermapen® is a registered trademark of Derma Pen, LLC

Numb Master Uses:

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We’re a lidocaine cream designed for use in microdermabrasion, for getting or removing tattoos, for bikini waxes, or even for injections or shots.

With a formula that uses 5% lidocaine – the strongest over-the-counter amount available – our topical anesthetic is perfect for quick, localized treatments that require a bit of pain insensitivity. Plus, when combined with micro-needling procedures, studies have shown that our numbing cream is even more effective than usual.

We’re also very effective in: Blood tests, inoculations, cannulations, hair removal, and basic cosmetic procedures

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