# K200911: MIRA Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Phakos
- Decided: Jun 2, 2020 after 57 days
- Product code: HRN (Unit, Cryophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K874555 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162756: PHAKOS Disposable Retinal Cryo Probe, Phakos (2017) Summary page 4.
- K180195: Frigitronics adapter, Phakos (2018) Summary page 4.

## Indications for use
The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.

Source page: https://510kreport.com/device/K200911
Methodology: https://510kreport.com/methodology