# K972872: Derma K Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Esc Medical Systems, Ltd.
- Decided: Oct 28, 1997 after 85 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: 3 generations back to K954013 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965015: Topaz 30 Surgical Laser System, Esc Medical Systems, Inc. (1997) Summary page 1.
- K964253: Derma  20 Laser System, Esc Medical Systems, Ltd. (1997) Summary page 1.

## Indications for use
The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissue.

Source page: https://510kreport.com/device/K972872
Methodology: https://510kreport.com/methodology