Biolitec, Inc. · Class II · Cleared May 18, 2001
| K-number | K010689 |
| Device name | MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM |
| Applicant | Biolitec, Inc. |
| Product code | GEX |
| Device class | Class II |
| Decision date | May 18, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
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