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MCL 31 Dermablate

Asclepion Laser Technologies GmbH

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

Product code GEX· 21 CFR 878.4810

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Company

Asclepion Laser Technologies GmbH
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

6
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Device details

FDA 510(k) registration fields

K number
K150140
Device name
MCL 31 Dermablate
Company
Asclepion Laser Technologies GmbH
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-01-22
Decision date
2015-06-05
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

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).

Intended Use

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).

Device Description

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 is operated with a handpiece of larger spotsize. The system incorporates a suction unit for the safe removal of laser plume.

Summary parsed at:2026-06-01 06:10:50 UTC

Predicate devices

2

K150140 references 2 predicate/reference devices

Cited as predicate

6

6 submissions cite K150140 as a predicate