HPC — Set, Lens, Trial, Ophthalmic Class I

FDA Device Classification

Classification Details

Product Code
HPC
Device Class
Class I
Regulation Number
886.1405
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K945443bobesBOBES LENS SETJuly 19, 1995
K951437oti medicalOTI MODEL TLS-60April 11, 1995
K930195optimark accessories and instrumentsOPHTHALMIC TRIAL LENSESJanuary 6, 1994
K934859arno intlCONTACT LENSESDecember 21, 1993
K930446marco ophthalmicMARCO TRIAL SETSJuly 6, 1993
K924786r.h. burtonBURTON TRIAL LENS SETApril 14, 1993
K920571r.h. burtonTRIAL LENS SETMay 7, 1992
K900478woodlynWOODLYN FULL APERTURE TRIAL LENS SETFebruary 21, 1990
K873907richmond productsCONFIRMATION TESTSDecember 29, 1987
K852056ascon medical instrumentsACC CROSS CYLINDERSJune 5, 1985
K843095optek medico coTRIA LENS SETOctober 5, 1984
K841766woodlynWOODLYN CLASSIC TRIAL LENS SETJune 1, 1984
K770389codman and shurtleffLENS SET, MENTOR TRIALMarch 14, 1977