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KYE — Inserter/Remover Contact Lens Class I

FDA Device Classification

FDA product code KYE covers "Inserter/Remover Contact Lens", a Class I medical device regulated under 21 CFR 886.5420. Submissions are reviewed by the Ophthalmic panel. At least 12 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KYE
Device Class
Class I
Regulation Number
886.5420
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K872567magnivisionSOFT CONTACT LENS REMOVERAugust 10, 1987
K872591magnivisionHARD CONTACT LENS REMOVER. ITEM #289August 4, 1987
K871130s. m. c. medi-techCONTACT LENS TWEEZERSMay 12, 1987
K870072dayton mfgSUMMIT OPTICS CONTACT LENS REMOVERFebruary 12, 1987
K850983marlin industriesMARLIN SOFT LENS TWEEZERSeptember 10, 1985
K850984marlin industriesMARLIN SOFT LENS HANDLERSeptember 10, 1985
K830738jermyn specialties of californiaLENSERT CONTACT LENS CLEANING & INSERTJune 10, 1983
K830496dmv contact lensDMV ANGLERMarch 9, 1983
K782140mcmurray and pendergostREMOVER, SOFT-SERT CONTACT LENSFebruary 12, 1979
K780931soft-sertSOFT LENS INSERTERJune 28, 1978
K780663dmv contact lensCONTACT LENS REMOVER AND INSERTERMay 17, 1978
K780664dmv contact lensSOFT LENS REMOVER/INSERTER/MANIPULATORMay 17, 1978

FDA data resources