# K121675: Versavit

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: Jun 21, 2012 after 15 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911808 (1991). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 1.

## Most influential descendants
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector) (2015), 5 descendants of its own
- K190875: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (2019), 2 descendants of its own
- K213467: EVA NEXUS Ophthalmic Surgical System (2022), 1 descendant of its own
- K212241: Quatera 700 (2022), 1 descendant of its own
- K250501: System Sophi (2025), 0 descendants of its own

## Recalls of this device
- Aug 11, 2016 · Class II · Z-0120-2017: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
- Aug 11, 2016 · Class II · Z-0119-2017: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
- Aug 11, 2016 · Class II · Z-0121-2017: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
- Aug 11, 2016 · Class II · Z-0122-2017: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

## Indications for use
The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.

Source page: https://510kreport.com/device/K121675
Methodology: https://510kreport.com/methodology