MEDICAL DIODE LASER SYSTEMS— 510(k) K160549
Substantially EquivalentWuhan Gigaa Optronics Technology Co., Ltd.
FDA 510(k) clearance K160549 for MEDICAL DIODE LASER SYSTEMS, Substantially Equivalent on 2017-04-07. Applicant: Wuhan Gigaa Optronics Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Wuhan Gigaa Optronics Technology Co., Ltd.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Lake Development Zone, Wuhan, CN
Recent devices under product code GEX
view allMore clearances from Wuhan Gigaa Optronics Technology Co., Ltd.
view allAdverse 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.