# K081541: Dermablate Effect

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Feb 23, 2009 after 266 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
85 later devices descend from it; 6 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MCL 30 Dermablate: named in the summary without a submission number
- (no number) Lux2940 Erbium Fractional Handpiece: named in the summary without a submission number
- (no number) Profile ProFractional Handpiece: named in the summary without a submission number
- (no number) Photosilk Plus: named in the summary without a submission number
- (no number) Cellactor SC1: named in the summary without a submission number
- (no number) D-Actor 200: named in the summary without a submission number

## Most influential descendants
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own

## Indications for use
The Dermablate Effect Er:YAG laser with handpiece of larger spot sizes is intended for use for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery and ophthalmology (skin around the eyes). The Dermablate Effect Er:YAG laser with fractional handpiece is intended for dermatological and skin resurfacing procedures. The Dermablate Effect can be equipped optionally with the following modules: Asclepion Pulsed Light (APL) and Acoustic Wave (AW). The Asclepion Pulsed Light is intended for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne. The Acoustic Wave is intended for the acti~,ation of connective tissue.

Source page: https://510kreport.com/device/K081541
Methodology: https://510kreport.com/methodology