The following data is part of a premarket notification filed by Biophotas Inc with the FDA for Biophotas Celluma3.
| Device ID | K171323 |
| 510k Number | K171323 |
| Device Name: | BIOPHOTAS CELLUMA3 |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Biophotas Inc 1000 E. Howell Ave. Ste A Anaheim, CA 92805 |
| Contact | Patrick Johnson |
| Correspondent | Steven Baker ISMART Consulting US 1004 West Tuscany View Road #205 Midvale, UT 84047 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-05 |
| Decision Date | 2017-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850523007600 | K171323 | 000 |
| 00850523007501 | K171323 | 000 |
| 00850523007181 | K171323 | 000 |
| 00850523007174 | K171323 | 000 |
| 00850523007143 | K171323 | 000 |
| 00850523007129 | K171323 | 000 |
| 00850523007075 | K171323 | 000 |
| 00850523007051 | K171323 | 000 |
| 00850523007037 | K171323 | 000 |