The following data is part of a premarket notification filed by Beijing Syntech Laser Co., Ltd. with the FDA for Diode Laser.
| Device ID | K123483 |
| 510k Number | K123483 |
| Device Name: | DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING SYNTECH LASER CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING SYNTECH LASER CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970285174281 | K123483 | 000 |
| 06970285174168 | K123483 | 000 |