# K962791: New Star Model 130 6-Watt ND: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Mar 13, 1997 after 239 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 K820106 (1982). 5 ancestors in all.
726 later devices descend from it; 3 cite it directly.
0 of 732 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952489: 6 Watt Holmium Laser System, New Star Lasers, Inc. (1996) Summary page 1.
- K912703: Optica 60 ND;Yag Surgical Laser System, Xintec Corporation (1991) Summary page 1.
- K932376: Zeiss Opmilas 144 Surgical Lasers, Carl Zeiss, Inc. (1993) Summary page 1.
- K933322: Zeiss Opmilas 144 Surgical Lasers, Carl Zeiss, Inc. (1993) Summary page 1.
- K820106: X-Ray Guaze Sponges, Stan-Pak Ent. (1982) Summary page 1.
- (no number) Gebauer Fluro-Ethyl topical refrigerant: named in the summary without a submission number

## Most influential descendants
- K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems (2002), 668 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022817: Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model Cooltouch-II (2002), 575 descendants of its own
- K022466: Profile 1320 Laser System (2002), 520 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own

## Indications for use
For use in dermatology for incision, excision, ablation and vaporization with hemostatis of soft tissue.

Source page: https://510kreport.com/device/K962791
Methodology: https://510kreport.com/methodology
