LASER PERIPHERALS HOLMIUM BARE FIBERS— 510(k) K972272

Substantially Equivalent

Laser Peripherals, LLC

FDA 510(k) clearance K972272 for LASER PERIPHERALS HOLMIUM BARE FIBERS, Substantially Equivalent on 1997-07-29. Applicant: Laser Peripherals, LLC.

Clearance details

Applicant: Laser Peripherals, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1997-06-18
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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.