# K990064: DI-Rhex Ophthalmic Diathermy System

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Technologies, Inc.
- Decided: Apr 4, 1999 after 86 days
- Product code: HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4100
- 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 K962135 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962135: D.O.R.C. Microdiathermy System, Dutch Ophthalmic USA, Inc. (1996) Summary page 1.
- K980170: Surgitron, Ellman Intl., Inc. (1998) Summary page 1.

## Indications for use
The OTI Di-rhex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, end for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.

Source page: https://510kreport.com/device/K990064
Methodology: https://510kreport.com/methodology