EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS— 510(k) K901204
Substantially EquivalentNiic U.S.A., Inc.
FDA 510(k) clearance K901204 for EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS, Substantially Equivalent on 1990-06-05. Applicant: Niic U.S.A., Inc..
Clearance details
- Applicant
- Niic U.S.A., Inc.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, 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.