The following data is part of a premarket notification filed by Biophotas, Inc. with the FDA for Biophotas Celluma.
| Device ID | K131113 |
| 510k Number | K131113 |
| Device Name: | BIOPHOTAS CELLUMA |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | BIOPHOTAS, INC. 28241 CROWN VALLEY PARKWAY, SUITE 510(K) Laguna Niguel, CA 92677 |
| Contact | Shepard G Bentley |
| Correspondent | Shepard G Bentley BIOPHOTAS, INC. 28241 CROWN VALLEY PARKWAY, SUITE 510(K) Laguna Niguel, CA 92677 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-22 |
| Decision Date | 2014-01-15 |
| Summary: | summary |