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510(k) K180195

Frigitronics adapter by Phakos — Product Code HRN

K180195 is an FDA 510(k) premarket notification submitted by Phakos for the device "Frigitronics adapter". The FDA issued a decision of Substantially Equivalent on March 16, 2018. The device falls under product code HRN (Unit, Cryophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.4170. Phakos has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2018
Date Received
January 24, 2018
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

  • K200911 — MIRA Adapter (June 2, 2020)
  • K173944 — Endocular Viewing Lenses and Silicone Ring (October 25, 2018)
  • K162756 — PHAKOS Disposable Retinal Cryo Probe (May 3, 2017)

Other clearances for product code HRN

  • K200911 — MIRA Adapter (June 2, 2020)
  • 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)
  • 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