# K960522: Diopexy Probe

- Pathway: 510(k) (Traditional)
- Applicant: Iriderm Div.
- Decided: Jul 19, 1996 after 164 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- 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 K872362 (1987). 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)
- K872362: Frigitronics Acc-1000 Capsule Cutter, Frigitronics of Connecticut, Inc. (1987) Summary page 1.
- K891282: Mic-100 with Cryoprobes, Frigitronics of Connecticut, Inc. (1989) Summary page 1.
- K903288: Iris Oculight SL Diode Laser Photocoag/Modified, Iriderm Div. (1990) Summary page 1.
- K915236: Iris G-Probe, Iriderm Div. (1994) Summary page 1.
- (no number) MIRA MD-1000 Microdiathermy System: named in the summary without a submission number

## Indications for use
The intended use of this device is transscleral retinal photocoagulation (TSRPC) for retinopexy.

Source page: https://510kreport.com/device/K960522
Methodology: https://510kreport.com/methodology