# K983984: Cooltouch V ND:Yag

- Pathway: 510(k) (Traditional)
- Applicant: Laser Aesthetics, Inc.
- Decided: Jun 7, 1999 after 210 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.
520 later devices descend from it; 1 cites it directly.
0 of 521 devices 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) Laser Aesthetics NS 130 “CoolTouch” Nd:YAG Laser System: named in the summary without a submission number
- (no number) HGM Veinlase Nd:YAG Laser System: named in the summary without a submission number
- (no number) Laserscope Orion Nd:YAG Laser System: named in the summary without a submission number

## Most influential descendants
- K012982: Cooltouch Varizoom (2001), 519 descendants of its own
- K032459: Profile 1320 Laser System (2004), 518 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own

## Indications for use
The Laser Aesthetics Nd:YAG Surgical Laser Model COOLTOUCH “y” is indicated for the coagulation and hemostasis of vascular lesions and soft tissue.

Source page: https://510kreport.com/device/K983984
Methodology: https://510kreport.com/methodology