# K953585: Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium Laser

- Pathway: 510(k) (Traditional)
- Applicant: Schwartz Electro-Optics, Inc.
- Decided: Feb 5, 1996 after 188 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.
64 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K962902: Fotona Skinlight Laser System (1997), 63 descendants of its own
- K971648: Sharplan Erbium: Yag Laser (4020) (1997), 58 descendants of its own
- K981438: Dornier Medilas E (1998), 56 descendants of its own
- K050317: Burane XL (2005), 53 descendants of its own
- K052806: Burane (2005), 52 descendants of its own

Source page: https://510kreport.com/device/K953585
Methodology: https://510kreport.com/methodology