LKX — Device, Thermal, Hemorrhoids Class U

FDA Device Classification

Classification Details

Product Code
LKX
Device Class
Class U
Regulation Number
Submission Type
Review Panel
GU
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172358privi medical pteInstaliefJanuary 10, 2018
K113660cryotherapy productsCOLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICALMay 3, 2012
K072414lil drug store productsCRYOSTATApril 7, 2008
K042564fama holdings internationalHEMOR-RITE CRYOTHERAPHYSeptember 30, 2005
K012746behiveICE BATONNovember 14, 2001
K981428cryoptherapy pain relief productsANU ICEJuly 7, 1998
K973590a.stein - regulatory affairs consultingHEMORRELIEF DEVICEFebruary 5, 1998
K944874medical appliance researchZEROID HEMORRHOIDAL DEVICEAugust 7, 1995
K921189zewaTHERMA-HAugust 31, 1992
K905276kure swiss medical agTHERMA-HNovember 7, 1991
K883984bio-dyneHEMORX COLD PACKDecember 22, 1988
K862490j. and jpANU-RXAugust 18, 1986
K855150hpk internationalHPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDSApril 1, 1986
K854569technology 2000HEMOR-ICEFebruary 5, 1986
K852679j. and jpMULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICEAugust 9, 1985
K822649dunmoreDEVICE FOR THE TREATMENT OF HEMORRHOIDSNovember 3, 1982
K822217luther medical productsTHERMOTHERAPYSeptember 24, 1982
K812567american pharmaceutical coRELIEFNovember 10, 1981