The following data is part of a premarket notification filed by Visioncare Devices, Inc. with the FDA for Procare Plus Vitrectomy System.
| Device ID | K120170 |
| 510k Number | K120170 |
| Device Name: | PROCARE PLUS VITRECTOMY SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | VISIONCARE DEVICES, INC. 1246 REDWOOD BLVD. Redding, CA 96003 |
| Contact | Kurtis Montegna |
| Correspondent | Kurtis Montegna VISIONCARE DEVICES, INC. 1246 REDWOOD BLVD. Redding, CA 96003 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-19 |
| Decision Date | 2012-05-30 |
| Summary: | summary |