# K965015: Topaz 30 Surgical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Esc Medical Systems, Inc.
- Decided: Mar 14, 1997 after 88 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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

Source page: https://510kreport.com/device/K965015
Methodology: https://510kreport.com/methodology