# K072424: Cooltouch, Model LC215,Coollipo

- Pathway: 510(k) (Special)
- Applicant: New Star Lasers, Inc.
- Decided: Oct 3, 2007 after 35 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.
194 later devices descend from it; 2 cite it directly.
0 of 195 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) CoolTouch CT3S Nd:YAG Laser System: named in the summary without a submission number

## Most influential descendants
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
The CoolTouch Model LC215 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 trophic acne scars, and; d) for treatment of reflux gr t and small saphenous veins associatedwithvaricIe a varicosities.

Source page: https://510kreport.com/device/K072424
Methodology: https://510kreport.com/methodology