# K964253: Derma  20 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Esc Medical Systems, Ltd.
- Decided: Apr 11, 1997 after 169 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: 2 generations back to K954013 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 1.
- K962902: Fotona Skinlight Laser System, Medical Laser Solutions (1997). Cleared while this submission was under review Summary page 1.
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.

## Most influential descendants
- K972872: Derma K Laser System (1997), 0 descendants of its own

## Indications for use
Incision, excision, ablation, vaporization and hemostasis of soft tissue

Source page: https://510kreport.com/device/K964253
Methodology: https://510kreport.com/methodology