FDA Product Code LYL: Accessories, Solution, Ultrasonic Cleaners For Lenses
Leading manufacturers include Eaton Medical Corp., Lens Comfort, Inc. and Bausch & Lomb, Inc..
22
Total
22
Cleared
167d
Avg days
1988
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Accessories, Solution, Ultrasonic Cleaners For Lenses Devices (Product Code LYL)
22 devices
Cleared
Jan 13, 2022
3N Contact Lenses Adjunct Cleaner
Suzhou 3N Biological Technology Co., Ltd.
Ophthalmic
255d
Cleared
Apr 01, 2021
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
Vuesonic, LLC
Ophthalmic
57d
Cleared
Nov 18, 2009
BPZ02 MULTIPURPOSE SOLUTION
Bausch & Lomb, Inc.
Ophthalmic
336d
Cleared
Dec 16, 2002
AUTOLENS CLEANING AND DISINFECTING UNIT
Autolens, Inc.
Ophthalmic
208d
Cleared
Nov 19, 2002
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Ciba Vision Corporation
Ophthalmic
98d
Cleared
May 31, 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
Bausch & Lomb, Incorporated
Ophthalmic
80d
Cleared
Feb 22, 2000
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
Strieter Clinical Research Laboratories, Inc.
Ophthalmic
88d
Cleared
Oct 01, 1999
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
Purilens, Inc.
Ophthalmic
113d
Cleared
Jan 13, 1999
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
Rim-Wide Companies, Inc.
Ophthalmic
211d
Cleared
Mar 02, 1998
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT
Lens Comfort, Inc.
Ophthalmic
74d
Cleared
Dec 20, 1996
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
Paladin Medical, Inc.
Ophthalmic
59d
Cleared
Nov 29, 1996
NEW COMFORT CONTACT LENS CARE ACCESSORY
Lens Comfort, Inc.
Ophthalmic
182d
Cleared
Jun 26, 1995
OPTI PADS
Karlen Mfg., Inc.
Ophthalmic
119d
Cleared
Mar 08, 1993
CONTACT LENS CLEANING ACCESSORY
Cramer Ent., Inc.
Ophthalmic
221d
Cleared
Nov 05, 1992
LENSONIC(TM) CONTACT LENS CARE ACCESSORY
Personal Professional Products, Inc.
Ophthalmic
213d
Cleared
Aug 25, 1992
THE CLEANER ACCESSORY
Eaton Medical Corp.
Ophthalmic
126d
Cleared
Oct 10, 1991
TURBOTRON 20/20
Prestige Manufacturing Snd Bhd
Ophthalmic
464d
Cleared
Jul 05, 1991
EASY EYES TM CONTACT LENS CLEANING MACHINE
Eaton Medical Corp.
Ophthalmic
253d
Cleared
Dec 21, 1990
THE VISONIC DOME(TM)
Vista Vision
Ophthalmic
213d
Cleared
Jun 23, 1989
SPIN-CLEAN CLEANING UNIT
Willmar Contact Lens Co.
Ophthalmic
78d
Cleared
Dec 29, 1988
CLENSATRON AUTOMATIC CONTACT LENS CLEANER
Questech Intl., Inc.
Ophthalmic
70d
Cleared
Oct 07, 1988
LENZ CLENZER
Lens Care, Inc.
Ophthalmic
165d
About Product Code LYL - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code LYL since 1988, with 22 receiving FDA clearance (average review time: 167 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.