The following data is part of a premarket notification filed by Zolar Technology & Mfg Co. Inc. with the FDA for Photon, Photon Plus.
| Device ID | K162114 |
| 510k Number | K162114 |
| Device Name: | Photon, Photon Plus |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Zolar Technology & MFG Co. Inc. 6315 Shawson Drive Mississauga, CA L5t 1j2 |
| Contact | Paul Atkins |
| Correspondent | Paul Atkins Zolar Technology & MFG Co. Inc. 6315 Shawson Drive Mississauga, CA L5t 1j2 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-29 |
| Decision Date | 2016-12-12 |
| Summary: | summary |