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Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter

by Keeler Instruments, Inc.

510(k) K112093

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK112093 Date8 Dec 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HRN
Device Class
Class II
Regulation
21 CFR Part 886.4170
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cryomatic Cryo Console is an ophthalmic cryophthalmic unit designed for cryosurgical procedures on the eye. It provides ac‑powered cryogenic delivery to create controlled freezing zones during retinal and other ocular surgeries.

The system is supplied with a single‑use disposable cryo probe and a disposable probe adapter. It is classified as a Class II medical device and has received FDA 510(k) clearance (K112093) as substantially equivalent under product code HRN. The console and accessories are intended for sterile, single‑use application in ophthalmic settings.

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