Cleared Traditional

CRYOMATIC

K062412 · Keeler Instruments, Inc. · Ophthalmic
Nov 2006
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K062412 is an FDA 510(k) clearance for the CRYOMATIC, 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 November 6, 2006, 81 days after receiving the submission on August 17, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K062412 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2006
Decision Date November 06, 2006
Days to Decision 81 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HRN — Unit, Cryophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4170

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