The following data is part of a premarket notification filed by Beijing Unt Technology Co., Ltd with the FDA for Diode Laser Therapy System.
| Device ID | K212978 |
| 510k Number | K212978 |
| Device Name: | Diode Laser Therapy System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING UNT Technology Co., Ltd M2-1 Area, Xinggu Development Zone, Pinggu District Beijing, CN 101200 |
| Contact | Qianwen Sheng |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-17 |
| Decision Date | 2021-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06976233581002 | K212978 | 000 |