Manufacturer
Asclepion Laser Technologies GmbHDermablate
Asclepion Laser Technologies GmbH
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K241600
- Device name
- Dermablate
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-06-04
- Decision date
- 2024-07-03
- Submission type
- Special
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
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). Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
Intended Use
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). Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
Device Description
Dermablate 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 device 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). The laser is a modification to previously cleared MCL 31 Dermablate due the following main technical modifications: Increase of max pulse energy to 3J. Adding of a microbeam handpiece named 'DeepSpot'. Hardware and software changes were implemented to accommodate the changes mentioned above. The modified device has the same intended use of the unmodified device. Moreover, the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
Summary parsed at:2026-06-01 05:28:28 UTC
Predicate devices
2ERISE Laser handpiece
MCL 31 Dermablate System
K241600 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241600 as a predicate
