# K103338: Cooltouch

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Nov 1, 2011 after 351 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092964: Cooltouch Varia ND:Yag Laser System, New Star Lasers, Inc. (2009) Summary page 1.
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010). Our OCR of the scanned summary read K093457, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “PinPointe USA, Inc. PinPointe FootLaser Nd:YAG laser system”. Summary page 3.

## Recalls of this device
- Sep 19, 2016 · Class II · Z-2915-2016: FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.

## Indications for use
For CoolTouch VariaBreeze™ with CoolBreeze® Handpiece: Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. For CoolTouch VariaBreeze™ with Toenail Handpiece: Indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Source page: https://510kreport.com/device/K103338
Methodology: https://510kreport.com/methodology