510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KYEClass I

Inserter/Remover Contact Lens

21 CFR 886.5420 / Ophthalmic
FDA source (opens on fda.gov)

KYE is the FDA product code for Inserter/Remover Contact Lens, a class I device type, regulated under 21 CFR 886.5420. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KYE
Device name
Inserter/Remover Contact Lens
Regulation
21 CFR 886.5420
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code KYE

By decision year
12 clearances under product code KYE with a decision year between 1978 and 1987, 1987 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KYE by decision year
YearClearances
19783
19791
19832
19852
19874

Applicants with the most clearances

Product code KYE
Applicants holding the most 510(k) clearances under product code KYE
ApplicantClearances
Dmv Contact Lens Co.3
FGX International Inc.2
Marlin Industries2
Dayton Mfg. Co.1
Jermyn Specialties of California1
Mcmurray and Pendergost1
S. M. C. Medi-Tech Corp.1
Soft-Sert1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order