Cleared Traditional

K012821 - D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM

K012821 is an FDA 510(k) clearance for D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM, manufactured by Dutch Ophthalmic USA, Inc.. The device is a Class 2 Ophthalmic device with product code HRN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K012821 · Dutch Ophthalmic USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
60d
Days
Class 2
Risk

K012821 is an FDA 510(k) clearance for the D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM. Classified as Unit, Cryophthalmic, Ac-powered (product code HRN), Class II - Special Controls.

Submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on October 22, 2001 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4170 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dutch Ophthalmic USA, Inc. devices

FDA 510(k) Submission Details - K012821

510(k) Number K012821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 110d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRN Device Classification - Class 2, Special Controls

Product Code HRN Unit, Cryophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HRN Unit, Cryophthalmic, Ac-powered

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