ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU— 510(k) K864887
Substantially Equivalent for Some IndicationsBio Quantum Technologies, Inc.
FDA 510(k) clearance K864887 for ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU, Substantially Equivalent for Some Indications on 1987-04-10. Applicant: Bio Quantum Technologies, Inc..
Clearance details
- Applicant
- Bio Quantum Technologies, Inc.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Houston, TX, 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.