The following data is part of a premarket notification filed by Vortex Surgical Inc with the FDA for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers.
| Device ID | K220263 |
| 510k Number | K220263 |
| Device Name: | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers |
| Classification | Photocoagulator And Accessories |
| Applicant | Vortex Surgical Inc 680 Crown Industrial Ct Ste F Chesterfield, MO 63005 |
| Contact | Andrew Ritts |
| Correspondent | Andrew Ritts Vortex Surgical Inc 680 Crown Industrial Ct Ste F Chesterfield, MO 63005 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-11-03 |