LYL · Accessories, Solution, Ultrasonic Cleaners For Lenses
Ophthalmic · 21 CFR 886.5928 · Class 2
Overview
| Product Code | LYL |
|---|---|
| Device Name | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Regulation | 21 CFR 886.5928 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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 | 3N Contact Lenses Adjunct Cleaner | Suzhou 3N Biological Technology Co., Ltd. | Jan 13, 2022 | SESE |
| K210300 | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System | Vuesonic, LLC | Apr 1, 2021 | SESE |
| K083757 | BPZ02 MULTIPURPOSE SOLUTION | Bausch & Lomb, Inc. | Nov 18, 2009 | SESE |
| K021699 | AUTOLENS CLEANING AND DISINFECTING UNIT | Autolens, Inc. | Dec 16, 2002 | SESE |
| K022687 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | Nov 19, 2002 | SESE |
| K020802 | RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION | Bausch & Lomb, Incorporated | May 31, 2002 | SESE |
| K994021 | CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION | Strieter Clinical Research Laboratories, Inc. | Feb 22, 2000 | SESE |
| K991965 | PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES | Purilens, Inc. | Oct 1, 1999 | SESE |
| K982115 | LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY | Rim-Wide Companies, Inc. | Jan 13, 1999 | SESE |
| K974724 | SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT | Lens Comfort, Inc. | Mar 2, 1998 | SESE |
| K964222 | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | Paladin Medical, Inc. | Dec 20, 1996 | SESE |
| K962112 | NEW COMFORT CONTACT LENS CARE ACCESSORY | Lens Comfort, Inc. | Nov 29, 1996 | SESE |
| K950940 | OPTI PADS | Karlen Mfg., Inc. | Jun 26, 1995 | SESE |
| K923816 | CONTACT LENS CLEANING ACCESSORY | Cramer Ent., Inc. | Mar 8, 1993 | SESE |
| K921615 | LENSONIC(TM) CONTACT LENS CARE ACCESSORY | Personal Professional Products, Inc. | Nov 5, 1992 | SESE |
| K921882 | THE CLEANER ACCESSORY | Eaton Medical Corp. | Aug 25, 1992 | SESE |
| K902920 | TURBOTRON 20/20 | Prestige Manufacturing Snd Bhd | Oct 10, 1991 | SESE |
| K904824 | EASY EYES TM CONTACT LENS CLEANING MACHINE | Eaton Medical Corp. | Jul 5, 1991 | SESE |
| K902306 | THE VISONIC DOME(TM) | Vista Vision | Dec 21, 1990 | SESE |
| K892372 | SPIN-CLEAN CLEANING UNIT | Willmar Contact Lens Co. | Jun 23, 1989 | SESE |
Top Applicants
- Lens Comfort, Inc. — 2 clearances
- Eaton Medical Corp. — 2 clearances
- Willmar Contact Lens Co. — 1 clearance
- Vuesonic, LLC — 1 clearance
- Vista Vision — 1 clearance
