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510(k) K131787

CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES by Keeler, Ltd. — Product Code HRN

K131787 is an FDA 510(k) premarket notification submitted by Keeler, Ltd. for the device "CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES". The FDA issued a decision of Substantially Equivalent on December 23, 2013. The device falls under product code HRN (Unit, Cryophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.4170. Keeler, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2013
Date Received
June 18, 2013
Clearance Type
Special
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 Keeler, Ltd.

  • K142179 — D-KAT Z-YPE (September 17, 2014)
  • K131589 — KEELER SLIT LAMP H-SERIES (June 27, 2013)
  • K093445 — KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) (January 19, 2010)

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)
  • 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