Cleared Special

CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES

K131787 · Keeler, Ltd. · Ophthalmic

Dec 2013

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K131787 is an FDA 510(k) clearance for the CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES, a Unit, Cryophthalmic, Ac-powered (Class II — Special Controls, product code HRN), submitted by Keeler, Ltd. (Broomall, US). The FDA issued a Cleared decision on December 23, 2013, 188 days after receiving the submission on June 18, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number	K131787 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2013
Decision Date	December 23, 2013
Days to Decision	188 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF