Dermablate

Asclepion Laser Technologies GmbH

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

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

2

K241600 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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