# K120170: Procare Plus Vitrectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Visioncare Devices, Inc.
- Decided: May 30, 2012 after 132 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896622 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980480: Syntec Vitman, Syntec, Inc. (1998) Summary page 1.
- K904909: I/a Vitrophage Model Ypr 2001, Visioncare Devices, Inc. (1991) Summary page 6.
- K896622: Visitec Vitrectomy Unit, Visitec Co. (1990) Summary page 3.

## Most influential descendants
- K212763: UniVit HE, UniVit UHS (2022), 0 descendants of its own

## Indications for use
The VOID HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module. The PROCARE PLUS TM Vitrectomy System is indicated for use in support of the following ophthalmic surgical procedures: Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis * Removal of lens fragments after cataract surgery; * Remove vitreous traction under the retina producing localized or complete retinal detachment * Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis; * Treatment of vitreous loss during cataract surgery; * Clean vitreous strands from the cataract wound; * Provide internal illumination for vitreous surgery; * Provide air pressure for maintaining intraocular pressure for retinal surgery.

Source page: https://510kreport.com/device/K120170
Methodology: https://510kreport.com/methodology