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510(k) K012821

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM by Dutch Ophthalmic USA, Inc. — Product Code HRN

K012821 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic USA, Inc. for the device "D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 22, 2001. The device falls under product code HRN (Unit, Cryophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.4170. Dutch Ophthalmic USA, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2001
Date Received
August 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

Other clearances by Dutch Ophthalmic USA, Inc.

  • K010082 — D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (March 12, 2001)
  • K983797 — D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM (March 3, 1999)
  • K980636 — FIBER OPTIC ENDOILLUMINATION PROBE (May 20, 1998)
  • K973229 — D.O.R.C. HEXON ILLUMINATION SYSTEM (November 25, 1997)
  • K973757 — D.O.R.C. SOLUX LIGHT SOURCE (November 7, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K940373 — OPHTHALMIC CRYO UNIT (July 18, 1994)
  • K902491 — ECKHARDT TEMPORARY KERATOPROSTHESIS (June 26, 1990)

Other clearances for product code HRN

  • K200911 — MIRA Adapter (June 2, 2020)
  • K180195 — Frigitronics adapter (March 16, 2018)
  • K162756 — PHAKOS Disposable Retinal Cryo Probe (May 3, 2017)
  • K160591 — D.O.R.C. Disposable Cryo Probe (January 23, 2017)
  • K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES (December 23, 2013)
  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K823768 — CLIRANS TE08 HOLLOW FIBER DIALYZER (January 8, 1983)

FDA data resources