Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5928](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5928) → LYL — Accessories, Solution, Ultrasonic Cleaners For Lenses # LYL · Accessories, Solution, Ultrasonic Cleaners For Lenses _Ophthalmic · 21 CFR 886.5928 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL ## Overview - **Product Code:** LYL - **Device Name:** Accessories, Solution, Ultrasonic Cleaners For Lenses - **Regulation:** [21 CFR 886.5928](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5928) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. ## Classification Rationale Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” ## Special Controls *Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K211361](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K211361.md) | 3N Contact Lenses Adjunct Cleaner | Suzhou 3N Biological Technology Co., Ltd. | Jan 13, 2022 | SESE | | [K210300](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K210300.md) | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System | Vuesonic, LLC | Apr 1, 2021 | SESE | | [K083757](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K083757.md) | BPZ02 MULTIPURPOSE SOLUTION | Bausch & Lomb, Inc. | Nov 18, 2009 | SESE | | [K021699](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K021699.md) | AUTOLENS CLEANING AND DISINFECTING UNIT | Autolens, Inc. | Dec 16, 2002 | SESE | | [K022687](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K022687.md) | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | Nov 19, 2002 | SESE | | [K020802](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K020802.md) | RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION | Bausch & Lomb, Incorporated | May 31, 2002 | SESE | | [K994021](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K994021.md) | CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION | Strieter Clinical Research Laboratories, Inc. | Feb 22, 2000 | SESE | | [K991965](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K991965.md) | PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES | Purilens, Inc. | Oct 1, 1999 | SESE | | [K982115](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K982115.md) | LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY | Rim-Wide Companies, Inc. | Jan 13, 1999 | SESE | | [K974724](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K974724.md) | SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT | Lens Comfort, Inc. | Mar 2, 1998 | SESE | | [K964222](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K964222.md) | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | Paladin Medical, Inc. | Dec 20, 1996 | SESE | | [K962112](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K962112.md) | NEW COMFORT CONTACT LENS CARE ACCESSORY | Lens Comfort, Inc. | Nov 29, 1996 | SESE | | [K950940](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K950940.md) | OPTI PADS | Karlen Mfg., Inc. | Jun 26, 1995 | SESE | | [K923816](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K923816.md) | CONTACT LENS CLEANING ACCESSORY | Cramer Ent., Inc. | Mar 8, 1993 | SESE | | [K921615](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K921615.md) | LENSONIC(TM) CONTACT LENS CARE ACCESSORY | Personal Professional Products, Inc. | Nov 5, 1992 | SESE | | [K921882](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K921882.md) | THE CLEANER ACCESSORY | Eaton Medical Corp. | Aug 25, 1992 | SESE | | [K902920](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K902920.md) | TURBOTRON 20/20 | Prestige Manufacturing Snd Bhd | Oct 10, 1991 | SESE | | [K904824](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K904824.md) | EASY EYES TM CONTACT LENS CLEANING MACHINE | Eaton Medical Corp. | Jul 5, 1991 | SESE | | [K902306](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K902306.md) | THE VISONIC DOME(TM) | Vista Vision | Dec 21, 1990 | SESE | | [K892372](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL/K892372.md) | SPIN-CLEAN CLEANING UNIT | Willmar Contact Lens Co. | Jun 23, 1989 | SESE | ## Top Applicants - Eaton Medical Corp. — 2 clearances - Lens Comfort, Inc. — 2 clearances - Autolens, Inc. — 1 clearance - Bausch & Lomb, Inc. — 1 clearance - Bausch & Lomb, Incorporated — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LYL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com