LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX— 510(k) K032991

Substantially Equivalent

Light Age, Inc.

FDA 510(k) clearance K032991 for LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX, Substantially Equivalent on 2004-09-14. Applicant: Light Age, Inc..

Clearance details

Applicant: Light Age, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2003-09-25
Decision date: 2004-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

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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.