The following data is part of a premarket notification filed by Synergetics, Inc with the FDA for Synergetics Directional Endoocular Laser Probe.
| Device ID | K113857 |
| 510k Number | K113857 |
| Device Name: | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE |
| Classification | Photocoagulator And Accessories |
| Applicant | SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
| Contact | Gary Oliveros |
| Correspondent | Gary Oliveros SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-04-23 |
| Summary: | summary |