# K012982: Cooltouch Varizoom

- Pathway: 510(k) (Special)
- Applicant: New Star Lasers, Inc.
- Decided: Oct 2, 2001 after 27 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 K983984 (1999). 1 ancestor in all.
519 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)
- K983984: Cooltouch V ND:Yag, Laser Aesthetics, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

## Indications for use
The CoolTouch VariZoom Variable Spot Size Reusable Fiber Optic Handpiece is indicated as an accessory for use with the CoolTouch “Varia” Nd:YAG Laser System, which has been cleared for the following indications: Hair removal (destruction of hair follicles) in all skin types and for soft tissue applications. For coagulation and hemostasis of vascular lesions. For pigmented lesions to reduce lesion size, for patients that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Source page: https://510kreport.com/device/K012982
Methodology: https://510kreport.com/methodology