COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM— 510(k) K010316

Name: FDA 510(k) clearance K010316
Creator: U.S. Food and Drug Administration
Published: 2001-05-01

Substantially Equivalent

Cooltouch Corp.

FDA 510(k) clearance K010316 for COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM, Substantially Equivalent on 2001-05-01. Applicant: Cooltouch Corp.. Device class: 2.

Clearance details

Applicant: Cooltouch Corp.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2001-02-02
Decision date: 2001-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, CA, US

Download summary PDF View on FDA.gov ↗

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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.