Tuesday 28 February 2017

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


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Friday 17 February 2017

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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Wednesday 8 February 2017

Micro Needling Eyebrows


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:

Hey there. We’re Numb Master.

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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