Procare Plus Vitrectomy System
FDA 510(k) K120170 · Visioncare Devices, Inc.
510(k) numberK120170
Submission
- Device name
- Procare Plus Vitrectomy System
- Applicant
- Visioncare Devices, Inc.
Redding, CA, US - Received
- January 19, 2012
- Decision date
- May 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
Other 510(k)s with product code HQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212763 | UniVit HE, UniVit UHSHQE · Traditional | Visioncare Devices, LLC | 08/10/2022SE |
| K170183 | Cetus system, Cetus probeHQE · Traditional | A.R.C Laser GmbH | 09/27/2017SE |
| K153168 | Bi-Blade Vitrectomy CutterHQE · Special | Medical Instrument Development Laboratories | 04/29/2016SE |
| K141065 | Constellation Vision SystemHQE · Traditional | Alcon Research, Ltd. | 08/22/2014SE |
| K121675 | VersavitHQE · Traditional | Synergetics, Inc. | 06/21/2012SE |
| K102222 | Ultimate Vit Enhamcer (Uve)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/08/2011SE |
| K033390 | Colibri Disposable Vitrectomy CutterHQE · Traditional | Microworld Medical Instruments, Inc. | 11/04/2003SE |
| K030948 | Vmate Model VMM1000HQE · Traditional | Howard Instruments, Inc. | 06/17/2003SE |
| K023939 | Velocity AdvantageHQE · Traditional | Visioncare Devices, Inc. | 04/17/2003SE |
| K020911 | Mid Labs Autonomous Vit Enhancer (Ave)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/29/2002SE |
More from Medical Instrument Development Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212763 | UniVit HE, UniVit UHSHQE · Traditional | 08/10/2022SE |
| K023939 | Velocity AdvantageHQE · Traditional | 04/17/2003SE |
| K971064 | Bayers Bimanual I/A HandpiecesHQC · Traditional | 06/09/1997SE |
| K940746 | Vit Cutter Model 94HQE · Traditional | 06/06/1994SE |
| K904909 | I/A Vitrophage Model Ypr 2001HQE · Traditional | 01/28/1991SE |
Questions and answers
When was Procare Plus Vitrectomy System cleared by the FDA?
Procare Plus Vitrectomy System (K120170) received a 510(k) decision of Substantially Equivalent on May 30, 2012, 132 days after the submission was received.
What is the product code of K120170?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.