The following data is part of a premarket notification filed by Ward Photonics Llc with the FDA for Photonica Professional.
| Device ID | K160880 |
| 510k Number | K160880 |
| Device Name: | Photonica Professional |
| Classification | Fat Reducing Low Level Laser |
| Applicant | Ward Photonics LLC 1980 N Atlantic Avenue Cocoa Beach, FL 32931 |
| Contact | Terry Ward |
| Correspondent | Jeff Brown Alliance Lifescience Partnerships, LLC 1260 Bell View Circle Sandy, UT 84094 |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-30 |
| Decision Date | 2016-09-23 |
| Summary: | summary |