The following data is part of a premarket notification filed by Ward Photonics Llc with the FDA for Photonica Professional.
| Device ID | K150336 |
| 510k Number | K150336 |
| Device Name: | Photonica Professional |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ward Photonics LLC 1980 N Atlantic Avenue Cocoa Beach, FL 32931 |
| Contact | Terry Ward |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-02-10 |
| Decision Date | 2015-02-24 |
| Summary: | summary |