COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II— 510(k) K003715

Substantially Equivalent

Cooltouch Corp.

FDA 510(k) clearance K003715 for COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II, Substantially Equivalent on 2001-03-01. Applicant: Cooltouch Corp..

Clearance details

Applicant: Cooltouch Corp.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2000-12-01
Decision date: 2001-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.