510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012821Substantially Equivalent

D.o.r.c. Cryostar Cryosurgical System

Dutch Ophthalmic USA, Inc., Kingston NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012821 is the FDA 510(k) clearance record for D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM, a class II device, cleared for Dutch Ophthalmic USA, Inc. on under FDA product code HRN (Unit, Cryophthalmic, Ac-Powered). FDA records list 10 510(k) clearances for Dutch Ophthalmic USA, Inc., from to . As of , FDA records show no recalls naming K012821.

Clearance record

Decision date
Received
(60 days to decision)
Product code
HRN Unit, Cryophthalmic, Ac-Powered
Regulation
21 CFR 886.4170
Device class
Class II
Review panel
Ophthalmic
Applicant
Dutch Ophthalmic USA, Inc. One Little River Rd., Kingston NH
510(k) summary
Summary
Third party review
No

Clearances, product code HRN

Trailing 12 months

FDA records hold no clearances under product code HRN in the trailing twelve months.

FDA records show no clearances under product code HRN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HRN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260