The following data is part of a premarket notification filed by Beijing Syntech Laser Co., Ltd. with the FDA for Trixel Co2 Laser.
| Device ID | K110434 |
| 510k Number | K110434 |
| Device Name: | TRIXEL CO2 LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING SYNTECH LASER CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-02-15 |
| Decision Date | 2011-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970285179095 | K110434 | 000 |
| 06970285179057 | K110434 | 000 |
| 06970285179026 | K110434 | 000 |