# K080163: Cooltouch Models LC215 and Coollipo

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Apr 10, 2008 after 78 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: 2 generations back to K062321 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072751: Cooltouch Models NS 160 and LC215 Coolipo, New Star Lasers, Inc. (2008) Summary page 5.
- K072424: Cooltouch, Model LC215,Coollipo, New Star Lasers, Inc. (2007) Summary page 5.

## Indications for use
In addition to previously cleared indications for use, the CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser is indicated for laser-assisted lipolysis.

Source page: https://510kreport.com/device/K080163
Methodology: https://510kreport.com/methodology