# K961710: Aoc Medical System Model Phase II 25 Surgical Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Optronics Corp.
- Decided: Nov 1, 1996 after 183 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AOC Medical Sys. AOC 25: named in the summary without a submission number
- (no number) Cynosure Phototome: named in the summary without a submission number
- (no number) Cytocare DioLase HP-1: named in the summary without a submission number
- (no number) DioMed DioMed 25: named in the summary without a submission number
- (no number) Indigo Medical IDE 830E: named in the summary without a submission number
- (no number) Sharplan Lasers 6020: named in the summary without a submission number

## Indications for use
The AOC Phase II 25 surgical diode laser system has the same general intended use as the predicate diode lasers. This intended use includes incision, excision, coagulation and vaporization applications in the following surgical specialties: Urology Gynecology Gastroenterology Pulmonology General and Thoracic Surgery Neurosurgery (hemostasis) Ear, Nose, and Throat; Head/Neck Surgery Dermatology/Plastic Surgery

Source page: https://510kreport.com/device/K961710
Methodology: https://510kreport.com/methodology