# K972028: Dermascan Surgical Laser Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Esc Medical Systems, Ltd.
- Decided: Oct 24, 1997 after 144 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 K955734 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964684: Softouch, Sahar Technologies, Inc. (1997) Summary page 1.
- K962242: Surescan, Clinicon Corp. (1996) Summary page 1.

## Indications for use
The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.

Source page: https://510kreport.com/device/K972028
Methodology: https://510kreport.com/methodology