MODEL LS 860, CO2 LASER— 510(k) K864562
Substantially Equivalent for Some IndicationsCooper Lasersonics, Inc.
FDA 510(k) clearance K864562 for MODEL LS 860, CO2 LASER, Substantially Equivalent for Some Indications on 1987-04-09. Applicant: Cooper Lasersonics, Inc..
Clearance details
- Applicant
- Cooper Lasersonics, Inc.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Santa Clara, 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.