NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810— 510(k) K101152
Substantially EquivalentFocus Medical, LLC
FDA 510(k) clearance K101152 for NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810, Substantially Equivalent on 2010-08-18. Applicant: Focus Medical, LLC.
Clearance details
- Applicant
- Focus Medical, LLC
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethel, CT, 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.