The following data is part of a premarket notification filed by Synergetics with the FDA for Synergetics Photon Ex.
| Device ID | K143123 |
| 510k Number | K143123 |
| Device Name: | Synergetics PHOTON EX |
| Classification | Endoilluminator |
| Applicant | Synergetics 3845 Corporate Centre Drive O'fallon, MO 63368 |
| Contact | Dan Regan |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-10-31 |
| Decision Date | 2015-02-24 |
| Summary: | summary |