# K062412: Cryomatic

- Pathway: 510(k) (Traditional)
- Applicant: Keeler Instruments, Inc.
- Decided: Nov 6, 2006 after 81 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: 1 generation back to K874555 (1988). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992954: Keeler Cryo Master & Probes, Keeler Instruments, Inc. (1999) Summary page 1.
- K874555: Keeler Acu 22XT Ophthalmic Cryo Unit, Keeler Instruments, Inc. (1988) Summary page 1.

## Most influential descendants
- K162756: PHAKOS Disposable Retinal Cryo Probe (2017), 2 descendants of its own
- K131787: Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes (2013), 2 descendants of its own
- K180195: Frigitronics adapter (2018), 1 descendant of its own
- K202038: CryoTreQ (2020), 0 descendants of its own
- K200911: MIRA Adapter (2020), 0 descendants of its own

## Indications for use
The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy of retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of follicles fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP)

Source page: https://510kreport.com/device/K062412
Methodology: https://510kreport.com/methodology