The following data is part of a premarket notification filed by Beijing Anchorfree Technology Co., Ltd with the FDA for Diode Laser Hair Removal System.
| Device ID | K141973 |
| 510k Number | K141973 |
| Device Name: | DIODE LASER HAIR REMOVAL SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING ANCHORFREE TECHNOLOGY CO., LTD P.O.BOX 237-023 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING ANCHORFREE TECHNOLOGY CO., LTD P.O.BOX 237-023 Shanghai, CN 200030 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-21 |
| Decision Date | 2014-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970441320019 | K141973 | 000 |