The following data is part of a premarket notification filed by Vortex Surgical Inc. with the FDA for Maxreach Laser Probe.
| Device ID | K191846 |
| 510k Number | K191846 |
| Device Name: | MAXReach Laser Probe |
| Classification | Photocoagulator And Accessories |
| Applicant | Vortex Surgical Inc. 680 Crown Industrial Ct. Suite F Chesterfield, MO 63005 |
| Contact | Bob Neu |
| Correspondent | Gary Oliveros Vortex Surgical Inc. 680 Crown Industrial Ct. Suite 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 | 2019-07-10 |
| Decision Date | 2019-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| VS01202518 | K191846 | 000 |
| VS01202316 | K191846 | 000 |
| VS01102719 | K191846 | 000 |
| VS01102517 | K191846 | 000 |
| VS01102319 | K191846 | 000 |