Atlas FDA

LYL

22 FDA 510(k) clearances · Product code

165 daysmedian time to decision
255 days90th percentile
22clearances measured

FDA profile

Official device name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5928
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
1999: 6 · 2005: 26 · 2006: 38 · 2010: 9 · 2011: 10 · 2012: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
3N Contact Lenses Adjunct Cleaner (K211361)Suzhou 3N Biological Technology Co., Ltd.2022-01-13
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System (K210300)Vuesonic, LLC2021-04-01
BPZ02 MULTIPURPOSE SOLUTION (K083757)Bausch & Lomb, Inc.2009-11-18
AUTOLENS CLEANING AND DISINFECTING UNIT (K021699)Autolens, Inc.2002-12-16
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K022687)Ciba Vision Corporation2002-11-19
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (K020802)Bausch & Lomb, Incorporated2002-05-31
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (K994021)Strieter Clinical Research Laboratories, Inc.2000-02-22
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (K991965)Purilens, Inc.1999-10-01
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (K982115)Rim-Wide Companies, Inc.1999-01-13
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT (K974724)Lens Comfort, Inc.1998-03-02
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (K964222)Paladin Medical, Inc.1996-12-20
NEW COMFORT CONTACT LENS CARE ACCESSORY (K962112)Lens Comfort, Inc.1996-11-29
OPTI PADS (K950940)Karlen Mfg., Inc.1995-06-26
CONTACT LENS CLEANING ACCESSORY (K923816)Cramer Ent., Inc.1993-03-08
LENSONIC(TM) CONTACT LENS CARE ACCESSORY (K921615)Personal Professional Products, Inc.1992-11-05
THE CLEANER ACCESSORY (K921882)Eaton Medical Corp.1992-08-25
TURBOTRON 20/20 (K902920)Prestige Manufacturing Snd Bhd1991-10-10
EASY EYES TM CONTACT LENS CLEANING MACHINE (K904824)Eaton Medical Corp.1991-07-05
THE VISONIC DOME(TM) (K902306)Vista Vision1990-12-21
SPIN-CLEAN CLEANING UNIT (K892372)Willmar Contact Lens Co.1989-06-23
CLENSATRON AUTOMATIC CONTACT LENS CLEANER (K884414)Questech Intl., Inc.1988-12-29
LENZ CLENZER (K881739)Lens Care, Inc.1988-10-07

Track LYL automatically

Every clearance here is in the API, with alerts when new ones post.