The following data is part of a premarket notification filed by Beijing Kes Biology Technology Co., Ltd. with the FDA for Nd: Yag Laser Therapy Systems.
| Device ID | K193477 |
| 510k Number | K193477 |
| Device Name: | Nd: YAG Laser Therapy Systems |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing Kes Biology Technology Co., Ltd. No. 15, Zone 2,Mafang Industrial Park, PingguyuanZhongguancun Science And Te Beijing, CN 101204 |
| Contact | Wei Meng Meng |
| Correspondent | Daina 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 | 2019-12-16 |
| Decision Date | 2020-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971513121039 | K193477 | 000 |