# K241600: Dermablate

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Jul 3, 2024 after 29 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
Longest line of descent: 22 generations back to K943450 (1995). 516 ancestors in all.
No later device cites it as a predicate yet.
0 of 517 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210634: MCL 31 Dermablate System, Asclepion Laser Technologies GmbH (2022) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K241600
Methodology: https://510kreport.com/methodology