The following data is part of a premarket notification filed by Visioncare Devices, Llc. with the FDA for Univit He, Univit Uhs.
| Device ID | K212763 |
| 510k Number | K212763 |
| Device Name: | UniVit HE, UniVit UHS |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | VisionCare Devices, LLC. 6100 Bellevue Lane Anderson, CA 96007 |
| Contact | Rick Morgan |
| Correspondent | Rick Morgan VisionCare Devices, LLC. 6100 Bellevue Lane Anderson, CA 96007 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-31 |
| Decision Date | 2022-08-10 |