D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM— 510(k) K012821

Name: FDA 510(k) clearance K012821
Creator: U.S. Food and Drug Administration
Published: 2001-10-22

Substantially Equivalent

Dutch Ophthalmic USA, Inc.

FDA 510(k) clearance K012821 for D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM, Substantially Equivalent on 2001-10-22. Applicant: Dutch Ophthalmic USA, Inc.. Device class: 2.

Clearance details

Applicant: Dutch Ophthalmic USA, Inc.
Product code: Code HRN
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 2001-08-23
Decision date: 2001-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRN

view all

K200911 — MIRA Adapter2020-06-02
K180195 — Frigitronics adapter2018-03-16
K162756 — PHAKOS Disposable Retinal Cryo Probe2017-05-03
K160591 — D.O.R.C. Disposable Cryo Probe2017-01-23
K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES2013-12-23

More clearances from Dutch Ophthalmic USA, Inc.

view all

K010082 — D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM2001-03-12
K983797 — D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM1999-03-03
K980636 — FIBER OPTIC ENDOILLUMINATION PROBE1998-05-20
K973229 — D.O.R.C. HEXON ILLUMINATION SYSTEM1997-11-25
K973757 — D.O.R.C. SOLUX LIGHT SOURCE1997-11-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.