# K954597: Right Angle Laser Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Mar 11, 1996 after 160 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: 1 generation back to K922497 (1994). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922497: Optilase ND:Yag Models 1000/4000 Surg Laser System, Trimedyne, Inc. (1994) Summary page 1.
- K932883: Optilase Model 1000-100 ND: Yag Laser System, Trimedyne, Inc. (1994). Our OCR of the scanned summary read K532883, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Trimedyne Optilase Nd:YAG Laser System”.

## Cited in the summary but kept off the family tree
- K844204: Emit QST Ethosuximide Assay, Syva Co. (1984). Our OCR of the scanned summary read K844204, FDA’s number for Emit QST Ethosuximide Assay (Syva Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Trimedyne Right Angle Laser Fiber”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation, and hemostasis for the treatment of benign prostatic hyperplasia (BPH) and other urological conditions.

Source page: https://510kreport.com/device/K954597
Methodology: https://510kreport.com/methodology