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 | K151890 |
| 510k Number | K151890 |
| 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 Ave, East Lake Development Z, 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 Ave, East Lake Development Z, 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 | 2015-07-10 |
| Decision Date | 2015-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970460900070 | K151890 | 000 |
| 06970460900063 | K151890 | 000 |
| 06970460900056 | K151890 | 000 |
| 06970460900049 | K151890 | 000 |
| 06970460900032 | K151890 | 000 |
| 06970460900025 | K151890 | 000 |
| 06970460900018 | K151890 | 000 |