MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM— 510(k) K870161
Substantially Equivalent for Some IndicationsCoherent Medical Group
FDA 510(k) clearance K870161 for MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM, Substantially Equivalent for Some Indications on 1987-04-14. Applicant: Coherent Medical Group. Device class: 2.
Clearance details
- Applicant
- Coherent Medical Group
- 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 for Some Indications
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
Recent devices under product code GEX
view allMore clearances from Coherent Medical Group
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.