The following data is part of a premarket notification filed by Biophotas, Inc with the FDA for Biophotas Celluma3.
| Device ID | K152280 |
| 510k Number | K152280 |
| Device Name: | BioPhotas Celluma3 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | BIOPHOTAS, INC 250 EL CAMINO REAL, #110 Tustin, CA 92780 |
| Contact | Patrick Johnson |
| Correspondent | Robert Seiple QPM CONSULTING, LLC 3817 SEVILLE RD Denton, TX 76205 |
| Product Code | ILY |
| Subsequent Product Code | OHS |
| Subsequent Product Code | OLP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-12 |
| Decision Date | 2016-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850523007747 | K152280 | 000 |
| 00850523007723 | K152280 | 000 |
| 00850523007716 | K152280 | 000 |
| 00850523007709 | K152280 | 000 |
| 00850523007938 | K152280 | 000 |
| 00850523007891 | K152280 | 000 |