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HPS — Unit, Cryophthalmic Class II

FDA Device Classification

Classification Details

Product Code
HPS
Device Class
Class II
Regulation Number
886.4170
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K202038vitreqCryoTreQDecember 30, 2020
K940373dutch ophthalmic usaOPHTHALMIC CRYO UNITJuly 18, 1994
K923629miraOPHTHALMIC TRICHIASIS PROBEOctober 19, 1992
K903303spembly medicalSPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESOctober 11, 1990
K874555keeler instrumentsKEELER ACU 22XT OPHTHALMIC CRYO UNITJanuary 29, 1988
K873388keeler instrumentsKEELER CTU CRYO SYSTEMNovember 13, 1987
K870195united surgicalUNITED SURGICAL CORP. CRYOPTIC PLUSFebruary 20, 1987
K833747mono research laboratoriesGALLIE CRYONUCLEATORMay 9, 1984
K801418keeler optical productsKEELER AMOILS ACULL CRYO OPHTHALMIC UNITJuly 21, 1980
K790102intermedicsMODEL 556-01 CRYOEXTRACTORFebruary 12, 1979
K781338edward weckBEAVER CATARACT CYROXTRACTORFebruary 12, 1979