# K150140: MCL 31 Dermablate

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Jun 5, 2015 after 134 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: 12 generations back to K943450 (1995). 151 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081541: Dermablate Effect, Asclepion Laser Technologies GmbH (2009) Summary page 5.
- K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A, Fotona D.D. (2011) Summary page 5.

## Most influential descendants
- K210634: MCL 31 Dermablate System (2022), 3 descendants of its own
- K153229: Superbium (2016), 2 descendants of its own
- K252561: BTL-754FF (2026), 0 descendants of its own
- K241600: Dermablate (2024), 0 descendants of its own
- K213761: Joule diVa System (2022), 0 descendants of its own

## 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).

Source page: https://510kreport.com/device/K150140
Methodology: https://510kreport.com/methodology