# K101783: Cooltouch Model CT3PZ, Cooltouch CT3 Plus Coolbreeze

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Sep 13, 2010 after 80 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 CT3 Nd:YAG laser system: named in the summary without a submission number
- (no number) CoolTouch CT3S Nd:YAG laser system: named in the summary without a submission number
- (no number) CoolTouch Varia Nd:YAG laser system: named in the summary without a submission number
- (no number) Patholase PinPointe FootLaser Nd:YAG laser system: named in the summary without a submission number

## Indications for use
The CoolTouch Model CT3PZ Nd:YAG Surgical Laser is indicated for the following: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for treatment of fine lines and wrinkles; for treatment of mild to moderate inflammatory acne vulgaris; for treatment of back acne and atrophic acne scars, and; for podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: matrixectomy periungal and subungal warts plantar warts radical nail excision neuromas

Source page: https://510kreport.com/device/K101783
Methodology: https://510kreport.com/methodology