MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP— 510(k) K120235

Name: FDA 510(k) clearance K120235
Creator: U.S. Food and Drug Administration
Published: 2012-09-17

Substantially Equivalent

Aerolase Medical Lasers, LLC

FDA 510(k) clearance K120235 for MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP, Substantially Equivalent on 2012-09-17. Applicant: Aerolase Medical Lasers, LLC. Device class: 2.

Clearance details

Applicant: Aerolase Medical Lasers, LLC
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2012-01-25
Decision date: 2012-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.