The following data is part of a premarket notification filed by Biotex, Inc. with the FDA for Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System.
| Device ID | K053087 |
| 510k Number | K053087 |
| Device Name: | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOTEX, INC. 8058 EL RIO ST. Houston, TX 77054 |
| Contact | Ashok Gowda |
| Correspondent | Ashok Gowda 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 | 2005-11-02 |
| Decision Date | 2006-03-01 |
| Summary: | summary |