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510(k) K162756

PHAKOS Disposable Retinal Cryo Probe by Phakos — Product Code HRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2017
Date Received
September 30, 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 Phakos

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  • K180195 — Frigitronics adapter (March 16, 2018)

Other clearances for product code HRN

  • K200911 — MIRA Adapter (June 2, 2020)
  • K180195 — Frigitronics adapter (March 16, 2018)
  • 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)
  • 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)