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

Accessories, Solution, Ultrasonic Cleaners For Lenses

21 CFR 886.5928 / Ophthalmic
FDA source (opens on fda.gov)

LYL is the FDA product code for Accessories, Solution, Ultrasonic Cleaners For Lenses, a class II device type, regulated under 21 CFR 886.5928. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
LYL
Device name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
22
Ingested recalls
14

Clearances, product code LYL

By decision year
22 clearances under product code LYL with a decision year between 1988 and 2022, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LYL by decision year
YearClearances
19882
19891
19901
19912
19922
19931
19951
19962
19981
19992
20001
20023
20091
20211
20221

Applicants with the most clearances

Product code LYL
Applicants holding the most 510(k) clearances under product code LYL
ApplicantClearances
Bausch & Lomb Incorporated2
Eaton Medical Corp.2
Lens Comfort, Inc.2
Autolens, Inc.1
Alcon Laboratories1
Cramer Ent., Inc.1
Karlen Mfg., Inc.1
Lens Care, Inc.1
Paladin Medical, Inc.1
Personal Professional Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code