Cleared Special

CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER

K112093 · Keeler Instruments, Inc. · Ophthalmic

Dec 2011

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K112093 is an FDA 510(k) clearance for the CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER, a Unit, Cryophthalmic, Ac-powered (Class II — Special Controls, product code HRN), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 8, 2011, 139 days after receiving the submission on July 22, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number	K112093 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2011
Decision Date	December 08, 2011
Days to Decision	139 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF