The following data is part of a premarket notification filed by Beijing Lead Beauty S & T Co., Ltd with the FDA for Q Switched Nd: Yag Laser Machine.
| Device ID | K193609 |
| 510k Number | K193609 |
| Device Name: | Q Switched Nd: YAG Laser Machine |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing Lead Beauty S & T Co., Ltd 202, No.5 Workshop, No.1 Caida 3rd Road Nancai Shunyi District Beijing, CN 101300 |
| Contact | Jiao Zhang |
| 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 | 2019-12-26 |
| Decision Date | 2020-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971679500020 | K193609 | 000 |