# K081628: Modification to Cooltouch, Models LC225 and Coollipo

- Pathway: 510(k) (Special)
- Applicant: New Star Lasers, Inc.
- Decided: Jun 20, 2008 after 10 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) CoolTouch LC215/CoolTouch CoolLipo Nd:YAG Laser System: named in the summary without a submission number

## Indications for use
The CoolTouch Model LC225/CoolTouch CoolLipo Nd:YAG Surgical Laser is indicated for the following: a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; b) for use in the treatment of fine lines and wrinkles; c) for treatment of back acne and atrophic acne scars; d) f6r treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; e) for laser-assisted lipolysis.

Source page: https://510kreport.com/device/K081628
Methodology: https://510kreport.com/methodology