Indigo Medical, Inc. · Class II · Cleared Dec 23, 1997
| K-number | K963969 |
| Device name | INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB |
| Applicant | Indigo Medical, Inc. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Dec 23, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
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