# K983797: D.O.R.C. Harmony Total Vitrectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic USA, Inc.
- Decided: Mar 3, 1999 after 126 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 K924222 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961310: Storz  Premiere II Microsurgical System (CX Series), Storz Instrument Co. (1996) Summary page 1.
- K932669: Supra-Vit (TM), Medical Instrument Development Laboratories, Inc. (1994) Summary page 1.
- K924222: Mid Labs, Inc. Vit Mate, Medical Instrument Development Laboratories, Inc. (1993) Summary page 1.
- K961738: Vit Commander System, Scieran Technologies, Inc. (1996) Summary page 1.
- (no number) Accurus: named in the summary without a submission number

## Indications for use
The D.O.R.C. Harmony Total vitrectomy system is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).

Source page: https://510kreport.com/device/K983797
Methodology: https://510kreport.com/methodology