Biotex, Inc. · Class II · Cleared Mar 1, 2006
| K-number | K053087 |
| Device name | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM |
| Applicant | Biotex, Inc. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Mar 1, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
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