# K980480: Syntec Vitman

- Pathway: 510(k) (Traditional)
- Applicant: Syntec, Inc.
- Decided: May 4, 1998 after 90 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K120170: Procare Plus Vitrectomy System (2012), 1 descendant of its own
- K212763: UniVit HE, UniVit UHS (2022), 0 descendants of its own

## Indications for use
The Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures: Removal of vitreous in cases of: Vitreous cloudiness Diabetic vitreal hemorrhaging Trauma, including contusions, penetrations, and intraocular foreign bodies, Opecity Inflammation Endophthalmitis Bacterial Fungal Uveitis Removal of lens remnants 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; Perforfi emuisification of cataractous lens and its removal by aspiration and irrigation; Provide internal illumination for vitreous surgery, Provide air pressure for maintaining intraocular pressure for retinal surgery.

Source page: https://510kreport.com/device/K980480
Methodology: https://510kreport.com/methodology