SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER— 510(k) K873760
Substantially Equivalent for Some IndicationsCoherent Medical Group
FDA 510(k) clearance K873760 for SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER, Substantially Equivalent for Some Indications on 1987-11-27. Applicant: Coherent Medical Group.
Clearance details
- Applicant
- Coherent Medical Group
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Palo Alto, CA, 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.