Asclepion Laser Technologies GmbH
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The MicroSpot handpiece is intended for dermatological procedures and skin resurfacing procedures. It is specifically indicated for dermatological procedures requiring resurfacing of soft tissue with a fractionated handpiece.
The MicroSpot handpiece is intended for Dermatological procedures and Skin resurfacing procedures.
The MicroSpot Handpiece is a handpiece with microbeam output to be used with the previously cleared MCL 31 Dermablate (K150140). The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. The MCL 31 can be operated with a handpiece of larger spotsize or with a microbeam handpiece. The system incorporates a suction unit for the safe removal of laser plume.
Summary parsed at:2026-06-01 06:11:32 UTC
