ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC— 510(k) K083915
Substantially EquivalentAdvanced Technology Laser Co., Ltd.
FDA 510(k) clearance K083915 for ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC, Substantially Equivalent on 2009-01-29. Applicant: Advanced Technology Laser Co., Ltd..
Clearance details
- Applicant
- Advanced Technology Laser Co., Ltd.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
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.