Product Code: LYL FDA class 2 21 CFR 886.5928

Accessories, Solution, Ultrasonic Cleaners For Lenses

Ophthalmic

Ultrasonic Lens Cleaner Solution Accessories (product code LYL) are ophthalmic products including cleaning solutions and accessories used in conjunction with ultrasonic cleaning devices for contact lenses, facilitating the removal of deposits and maintaining lens hygiene. Regulated under 21 CFR 886.5928 and classified as a Class 2 device, they require a 510(k) premarket notification and are eligible for third-party review. The devices fall under the Ophthalmic specialty. They are not implants and are not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LYL
Device Class: FDA class 2
Regulation Number: 886.5928
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K211361	3N Contact Lenses Adjunct Cleaner	Jan 13, 2022	Substantially Equivalent	Suzhou 3N Biological Technology Co., Ltd.
K210300	VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System	Apr 01, 2021	Substantially Equivalent	Vuesonic, LLC
K083757	BPZ02 MULTIPURPOSE SOLUTION	Nov 18, 2009	Substantially Equivalent	Bausch & Lomb, Inc.
K021699	AUTOLENS CLEANING AND DISINFECTING UNIT	Dec 16, 2002	Substantially Equivalent	Autolens, Inc.
K022687	AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION	Nov 19, 2002	Substantially Equivalent	Ciba Vision Corporation
K020802	RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION	May 31, 2002	Substantially Equivalent	Bausch & Lomb, Incorporated
K994021	CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION	Feb 22, 2000	Substantially Equivalent	Strieter Clinical Research Laboratories, Inc.
K991965	PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES	Oct 01, 1999	Substantially Equivalent	Purilens, Inc.
K982115	LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY	Jan 13, 1999	Substantially Equivalent	Rim-Wide Companies, Inc.
K974724	SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT	Mar 02, 1998	Substantially Equivalent	Lens Comfort, Inc.
K964222	ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING	Dec 20, 1996	Substantially Equivalent	Paladin Medical, Inc.
K962112	NEW COMFORT CONTACT LENS CARE ACCESSORY	Nov 29, 1996	Substantially Equivalent	Lens Comfort, Inc.
K950940	OPTI PADS	Jun 26, 1995	Substantially Equivalent	Karlen Mfg., Inc.
K923816	CONTACT LENS CLEANING ACCESSORY	Mar 08, 1993	Substantially Equivalent	Cramer Ent., Inc.
K921615	LENSONIC(TM) CONTACT LENS CARE ACCESSORY	Nov 05, 1992	Substantially Equivalent	Personal Professional Products, Inc.
K921882	THE CLEANER ACCESSORY	Aug 25, 1992	Substantially Equivalent	Eaton Medical Corp.
K902920	TURBOTRON 20/20	Oct 10, 1991	Substantially Equivalent	Prestige Manufacturing Snd Bhd
K904824	EASY EYES TM CONTACT LENS CLEANING MACHINE	Jul 05, 1991	Substantially Equivalent	Eaton Medical Corp.
K902306	THE VISONIC DOME(TM)	Dec 21, 1990	Substantially Equivalent	Vista Vision
K892372	SPIN-CLEAN CLEANING UNIT	Jun 23, 1989	Substantially Equivalent	Willmar Contact Lens Co.
K884414	CLENSATRON AUTOMATIC CONTACT LENS CLEANER	Dec 29, 1988	Substantially Equivalent	Questech Intl., Inc.
K881739	LENZ CLENZER	Oct 07, 1988	Substantially Equivalent	Lens Care, Inc.