Cleared Traditional

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM

K012821 · Dutch Ophthalmic USA, Inc. · Ophthalmic
Oct 2001
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K012821 is an FDA 510(k) clearance for the D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM, a Unit, Cryophthalmic, Ac-powered (Class II — Special Controls, product code HRN), submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on October 22, 2001, 60 days after receiving the submission on August 23, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K012821 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2001
Decision Date October 22, 2001
Days to Decision 60 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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