Manufacturer
Asclepion Laser Technologies GmbHMCL 31 Dermablate System
Asclepion Laser Technologies GmbH
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K210634
- Device name
- MCL 31 Dermablate System
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-03-03
- Decision date
- 2022-04-13
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
Intended Use
The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
Device Description
The MCL 31 Dermablate System is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The MCL 31 Dermablate System can be operated with micro beam and non‐micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot‐operated switch (footswitch).
Summary parsed at:2026-06-01 05:38:08 UTC
Predicate devices
2MCL 31 Dermablate
MicroSpot Handpiece
K210634 references 2 predicate/reference devices
Cited as predicate
3Joule diVa System
Dermablate
BTL-754FF
3 submissions cite K210634 as a predicate