K131113 is an FDA 510(k) clearance for the BIOPHOTAS CELLUMA. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Biophotas, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on January 15, 2014, 268 days after receiving the submission on April 22, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K131113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2013 |
| Decision Date | January 15, 2014 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILY - Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |