What is the Difference Between Microneedling Devices?
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So...let's start with the basics. The FDA has two categories for microneedling devices and it is based on the size of the needle depth. The two categories are cosmetic and medical microneedling. Cosmetic microneedling is a depth of 0.3mm or less where as medical is anything above that depth. Legally registered nurses, nurse practitioners, physician assistants, and physicians can perform medical microneedling in the state of California.
There are a number of microneedling devices out there. I am not going to even get into all the types of pens, stamps, dermal rollers, etc. However I will focus a little on some micrneedling pens or devices. Some devices market themselves as a microneedling pigmentation system to get around the need for FDA clearance. Some pens claim they go a specific depth but when actually tested do not go the depth they say they will. Furthermore the needles on the cartridge may not be as stra |
• Treats scars (e.g., acne scars, atrophic scars, hypertrophic scars, burn scars)
•Treats wrinkles and deep facial lines
• Treats cellulite and stretch marks
• Treats dermatoses
• Treats acne
• Treats alopecia (hair loss)
• Stimulates collagen production
• Stimulates angiogenesis
• Promotes wound healing
Instead the non-FDA cleared device will market saying one of the following things:
· facilitate exfoliation of the skin (i.e., disruption of the stratum corneum)
· improvement in the appearance of skin
· give skin a smoother look and feel
· give skin a luminous look
•Treats wrinkles and deep facial lines
• Treats cellulite and stretch marks
• Treats dermatoses
• Treats acne
• Treats alopecia (hair loss)
• Stimulates collagen production
• Stimulates angiogenesis
• Promotes wound healing
Instead the non-FDA cleared device will market saying one of the following things:
· facilitate exfoliation of the skin (i.e., disruption of the stratum corneum)
· improvement in the appearance of skin
· give skin a smoother look and feel
· give skin a luminous look
I am sure there are devices out there that may say they treat things they should not be saying, however, on that same note, knowing the information above, can it be trusted?
As stated above, there are currently 2 microneedling devices that are FDA cleared. One is only FDA cleared for acne scarring. The other has Double FDA Clearance for both wrinkles and acne scarring. It is the only one in the world that currently holds this type of FDA Clearance. Admittedly, this is the device Ananya Aesthetics uses. There are a variety of other reason why we chose to purchase this device over the other device (or any other for that matter), but this article is merely meant for educational purposes. However, if you are interested in finding out why, we are happy to discuss those reasons with you over the phone or in person.
As stated above, there are currently 2 microneedling devices that are FDA cleared. One is only FDA cleared for acne scarring. The other has Double FDA Clearance for both wrinkles and acne scarring. It is the only one in the world that currently holds this type of FDA Clearance. Admittedly, this is the device Ananya Aesthetics uses. There are a variety of other reason why we chose to purchase this device over the other device (or any other for that matter), but this article is merely meant for educational purposes. However, if you are interested in finding out why, we are happy to discuss those reasons with you over the phone or in person.
The Exceed Microneedling Device
The Exceed microneedling device is the first microneedling device to receive double FDA Clearance and is currently the only device that holds FDA Clearance for wrinkles. It also helps with skin texture, discoloration, and skin laxity. With a unique, six-needle tilting plate and patented safety membrane for powerful and precise skin punctuation at 900 punctures per second, the EXCEED high-end needle cartridge delivers outstanding results in safety and beauty. The tilting needle plate, adapts to the surface of the skin for perpendicular needle penetration, allows circular treatment for faster, more efficient treatment, and causes no sagging on the skin’s surface. The patented safety membrane prevents backflow of liquids to reduce the risk of contamination to the handpiece. The needles are of premium, high quality. This means they have high precision and penetration force allowing little to no recovery time (redness fades away shortly after recovery time), less pain for the patient, low risk of infection due to rapid closure of puncture, and less chance of undesirable effects. It is a conscious decision not to use cartridges with more needles. There are microneedle rollers and pens on the market, sometimes 12 needles, sometimes even up to 36 needles. This creates the so-called "fakir effect,"( the magic trick of a person lying on a bed of needles while getting a cinder block crushed on them). So, let's think of that bed of nails (the fakir) example. Because more needles distribute the pressure, it will be more difficult for them to penetrate the skin and therefore they are not effective. And if the needles do puncture the skin with a lot of force, however, this will be more careless and cracks can occur in the skin.
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References:
Sasaki, G. (2017). Micro-Needling Depth Penetration, Presence of
Pigment Particles, and Fluorescein-Stained
Platelets: Clinical Usage for Aesthetic Concerns. Aesthetic Surgery Journal 37 (1) 71-83.
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health. Regulatory Considerations for Microneedling Devices. Retrieved from: https://www.fda.gov/media/107708/download
https://us.amieamed.com/exceed-device/cartridge/
Sasaki, G. (2017). Micro-Needling Depth Penetration, Presence of
Pigment Particles, and Fluorescein-Stained
Platelets: Clinical Usage for Aesthetic Concerns. Aesthetic Surgery Journal 37 (1) 71-83.
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health. Regulatory Considerations for Microneedling Devices. Retrieved from: https://www.fda.gov/media/107708/download
https://us.amieamed.com/exceed-device/cartridge/