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 |