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

Lens, Guide, Intraocular

21 CFR 886.4300 / Ophthalmic
FDA source (opens on fda.gov)

KYB is the FDA product code for Lens, Guide, Intraocular, a class I device type, regulated under 21 CFR 886.4300. As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
KYB
Device name
Lens, Guide, Intraocular
Regulation
21 CFR 886.4300
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
39
Ingested recalls
7

Clearances, product code KYB

By decision year
39 clearances under product code KYB with a decision year between 1979 and 2015, 1986 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KYB by decision year
YearClearances
19791
19801
19811
19822
19831
19843
19865
19872
19881
19902
19943
19953
19961
19972
19982
20001
20021
20041
20073
20082
20151

Applicants with the most clearances

Product code KYB
Applicants holding the most 510(k) clearances under product code KYB
ApplicantClearances
Staar Surgical AG7
Alcon Laboratories4
Advanced Medical Optics, Inc.2
Chiron Ophthalmics2
Chiron Vision Corp.2
CooperVision, Inc.2
Duckworth & Kent, Ltd.2
Alcon Manufacturing, Ltd.1
Allergan1
American Medical Optics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order