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 |