SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS— 510(k) K963229
Substantially EquivalentSharplan Lasers, Inc.
FDA 510(k) clearance K963229 for SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS, Substantially Equivalent on 1996-11-05. Applicant: Sharplan Lasers, Inc.. Device class: 2.
Clearance details
- Applicant
- Sharplan Lasers, Inc.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warwick, RI, US
Recent devices under product code GEX
view allMore clearances from Sharplan Lasers, Inc.
view allAdverse 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.