# K162756: PHAKOS Disposable Retinal Cryo Probe

- Pathway: 510(k) (Traditional)
- Applicant: Phakos
- Decided: May 3, 2017 after 215 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: 2 generations back to K874555 (1988). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062412: Cryomatic, Keeler Instruments, Inc. (2006) Summary page 4.
- K112093: Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter, Keeler Instruments, Inc. (2011) Summary page 4.

## Most influential descendants
- K180195: Frigitronics adapter (2018), 1 descendant of its own
- K200911: MIRA Adapter (2020), 0 descendants of its own

## Indications for use
The PHAKOS Disposable Retinal Cryo Probe 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/K162756
Methodology: https://510kreport.com/methodology