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510(k) K200911

MIRA Adapter by Phakos — Product Code HRN

K200911 is an FDA 510(k) premarket notification submitted by Phakos for the device "MIRA Adapter". The FDA issued a decision of Substantially Equivalent on June 2, 2020. 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
June 2, 2020
Date Received
April 6, 2020
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

  • K173944 — Endocular Viewing Lenses and Silicone Ring (October 25, 2018)
  • K180195 — Frigitronics adapter (March 16, 2018)
  • K162756 — PHAKOS Disposable Retinal Cryo Probe (May 3, 2017)

Other clearances for product code HRN

  • 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)
  • 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