# K922497: Optilase ND:Yag Models 1000/4000 Surg Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Mar 1, 1994 after 643 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.
5 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K954597: Right Angle Laser Fibers (1996), 4 descendants of its own
- K970422: Right Angle Laser Fibers;Optilase ND:Yag Laser;Optilase PL100 ND Laser Systems (1997), 2 descendants of its own
- K053457: Vapormax II (2005), 1 descendant of its own
- K233157: VaporMAX LDD; MOJo LDD; MegaJOULE LDD (2024), 0 descendants of its own
- K991847: Thermoflex System (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K922497
Methodology: https://510kreport.com/methodology