Laser Peripherals, LLC Family of Bare Laser Fibers— 510(k) K170366
Substantially EquivalentLaser Peripherals, LLC
FDA 510(k) clearance K170366 for Laser Peripherals, LLC Family of Bare Laser Fibers, Substantially Equivalent on 2017-06-08. Applicant: Laser Peripherals, LLC.
Clearance details
- Applicant
- Laser Peripherals, LLC
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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, through . 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.