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510(k) K160591

D.O.R.C. Disposable Cryo Probe by Dutch Ophthalmic Research Center International BV — Product Code HRN

K160591 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic Research Center International BV for the device "D.O.R.C. Disposable Cryo Probe". The FDA issued a decision of Substantially Equivalent on January 23, 2017. The device falls under product code HRN (Unit, Cryophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.4170. Dutch Ophthalmic Research Center International BV has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2017
Date Received
March 1, 2016
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 Research Center International BV

  • K142877 — EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DOR (March 13, 2015)
  • K081877 — ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS (January 5, 2009)
  • K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (October 13, 2006)

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)
  • 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)
  • K012821 — D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (October 22, 2001)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K823768 — CLIRANS TE08 HOLLOW FIBER DIALYZER (January 8, 1983)

FDA data resources