Manufacturer
Asclepion Laser Technologies GmbHMicroSpot Handpiece
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
- K152153
- Device name
- MicroSpot Handpiece
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-08-03
- Decision date
- 2015-12-11
- Submission type
- Traditional
- Technology type
- Er:YAG(AI inferred)
- Clinical applications
- Skin resurfacing
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
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.
Intended Use
The MicroSpot handpiece is intended for Dermatological procedures and Skin resurfacing procedures.
Device Description
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
Predicate devices
4—
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Not ingested
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Not ingested
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Not ingested
MCL 31 Dermablate
K152153 references 4 predicate/reference devices
Cited as predicate
22940 nm Er:Yag Laser Handpiece
MCL 31 Dermablate System
2 submissions cite K152153 as a predicate