The following data is part of a premarket notification filed by Biotex, Inc. with the FDA for Photex Diode Laser Series, Models 980, 810 And 940.
Device ID | K060304 |
510k Number | K060304 |
Device Name: | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 |
Classification | Powered Laser Surgical Instrument |
Applicant | BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 |
Contact | Matthew Fox |
Correspondent | Matthew Fox BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-06 |
Decision Date | 2006-03-21 |
Summary: | summary |