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510(k) K042564

HEMOR-RITE CRYOTHERAPHY by Fama Holdings International Corp — Product Code LKX

K042564 is an FDA 510(k) premarket notification submitted by Fama Holdings International Corp for the device "HEMOR-RITE CRYOTHERAPHY". The FDA issued a decision of Substantially Equivalent on September 30, 2005. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2005
Date Received
September 21, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances for product code LKX

  • K172358 — Instalief (January 10, 2018)
  • K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (May 3, 2012)
  • K072414 — CRYOSTAT (April 7, 2008)
  • K012746 — ICE BATON (November 14, 2001)
  • K981428 — ANU ICE (July 7, 1998)
  • K973590 — HEMORRELIEF DEVICE (February 5, 1998)
  • K944874 — ZEROID HEMORRHOIDAL DEVICE (August 7, 1995)
  • K921189 — THERMA-H (August 31, 1992)
  • K905276 — THERMA-H (November 7, 1991)
  • K883984 — HEMORX COLD PACK (December 22, 1988)

FDA data resources