# K973764: Temperature Diagnostic Accessory

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Dec 31, 1997 after 90 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 K912703 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912703: Optica 60 ND;Yag Surgical Laser System, Xintec Corporation (1991) Summary page 1.

## Indications for use
The Temperature Diagnostic Accessory is intended for use as a semsing device to measure and display the temperature of the treatment area during procedures with the ND-130 Laser.

Source page: https://510kreport.com/device/K973764
Methodology: https://510kreport.com/methodology