Electronic cosmetic micro-needling handpiece

Definition
A non-sterile, hand-held, mains electricity (AC-powered) device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin (i.e., to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, hair loss) as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); the micro-needles are not part of the handpiece, however a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider. This is a reusable device.
GUDID devices
12
Last updated
2020-01-15 05:26:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
EMTDAD64201USMP0ExceedMT.DERM GmbHAD64201USMP2020-01-01
EMTDE104201USMP0Footswitch MT.DERM GmbHE104201USMP 2020-01-01
EMTDAD61USMP0ExceedMT.DERM GmbHAD61USMP2018-10-23
EMTDAD61USMP1ExceedMT.DERM GmbHAD61USMP2018-10-23
EMTDE100201USMP0Footswitch MT.DERM GmbHE100201USMP 2018-10-23
EMTDE100201USMP1Footswitch MT.DERM GmbHE100201USMP 2018-10-23
20863221000327SkinPen Precision Treatment KitsBellus Medical, LLC12018-05-29
00863221000316SkinPen Precision HandpieceBellus Medical, LLCREF1002018-04-09
00863221000323SkinPen Precision Treatment KitBellus Medical, LLCF5SP0132018-04-09
00863221000330SkinPen Precision Microneedling SystemBellus Medical, LLCREF100/REF1012018-04-09
00863221000347SkinPen Precision Charging BaseBellus Medical, LLCREF1012018-04-09
00863221000354SkinPen Precision Treatment KitsBellus Medical, LLC12018-04-12