# K012821: D.O.R.C. Cryostar Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic USA, Inc.
- Decided: Oct 22, 2001 after 60 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 K940373 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940373: Ophthalmic Cryo Unit, Dutch Ophthalmic USA, Inc. (1994) Summary page 1.
- K992954: Keeler Cryo Master & Probes, Keeler Instruments, Inc. (1999) Summary page 1.

## Most influential descendants
- K160591: D.O.R.C. Disposable Cryo Probe (2017), 0 descendants of its own

## Indications for use
The D.O.R.C. CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or anterior segment including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis and retinopathy of prematurity.

Source page: https://510kreport.com/device/K012821
Methodology: https://510kreport.com/methodology