The following data is part of a premarket notification filed by Wuhan Gigaa Optronics Technology Co., Ltd with the FDA for Medical Diode Laser Systems.
| Device ID | K160549 |
| 510k Number | K160549 |
| Device Name: | MEDICAL DIODE LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD 5, 6/F, UNIT A, B, BUILDING B8, HI-TECH MEDICAL DEVICE INDUSTRIAL PARK, #818 GAOXIN AVENUE East Lake Development Zone, Wuhan, CN 430206 |
| Contact | Nie Xinxing |
| Correspondent | Nie Xinxing WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD 5, 6/F, UNIT A, B, BUILDING B8, HI-TECH MEDICAL DEVICE INDUSTRIAL PARK, #818 GAOXIN AVENUE East Lake Development Zone, Wuhan, CN 430206 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2017-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970460900001 | K160549 | 000 |
| 06974632230019 | K160549 | 000 |