# K970422: Right Angle Laser Fibers;Optilase ND:Yag Laser;Optilase PL100 ND Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Apr 21, 1997 after 77 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: 2 generations back to K922497 (1994). 3 ancestors in all.
2 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)
- K954597: Right Angle Laser Fibers, Trimedyne, Inc. (1996) Summary page 1.

## Most influential descendants
- K053457: Vapormax II (2005), 1 descendant of its own
- K233157: VaporMAX LDD; MOJo LDD; MegaJOULE LDD (2024), 0 descendants of its own

## Indications for use
The Right Angle Laser Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH).

Source page: https://510kreport.com/device/K970422
Methodology: https://510kreport.com/methodology