PROLITE PULSED LIGHT SYSTEM— 510(k) K021304

Substantially Equivalent

Big Sky Laser Technologies, Inc.

FDA 510(k) clearance K021304 for PROLITE PULSED LIGHT SYSTEM, Substantially Equivalent on 2002-07-23. Applicant: Big Sky Laser Technologies, Inc..

Clearance details

Applicant: Big Sky Laser Technologies, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2002-04-24
Decision date: 2002-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bozeman, MT, 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.