Atlas FDA

MRC

33 FDA 510(k) clearances · Product code

84 daysmedian time to decision
202 days90th percentile
33clearances measured

FDA profile

Official device name
Products, Contact Lens Care, Rigid Gas Permeable
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5918
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2025: 74
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
cleadew GP hydra one (K251876)Ophtecs Corporation2025-10-09
Boston One Step Liquid Enzymatic Cleaner (K200416)Bausch & Lomb, Incorporated2020-09-23
VibrantVue Scleral Saline (K201069)Dry Eye Innovations, LLC2020-07-31
MaxiTears Contacts PF (K182984)Omnivision AG2019-07-24
Nutrifill (K181566)Contamac, Ltd.2018-10-22
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner (K181627)Bausch & Lomb, Incorporated2018-08-10
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution (K180319)Bausch and Lomb, Incorporated2018-03-27
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions (K173089)Bausch & Lomb, Incorporated2017-11-27
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K173136)Menicon Co, Ltd.2017-11-16
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION (K130805)Menicon Co, Ltd.2013-07-03
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS (K122273)Menicon Co, Ltd.2013-01-02
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES (K082855)Menicon Co, Ltd.2010-03-09
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, (K052074)Szabocsik and Associates2005-09-01
COMPLETE BLINK-N-CLEAN LENS DROPS (K040839)Advanced Medical Optics, Inc.2004-10-19
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION (K024289)Bausch & Lomb, Incorporated2003-05-02
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K023455)Ciba Vision Corporation2003-02-28
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES (K020930)Menicon Co, Ltd.2002-05-02
AQUIFY LENS COMFORT DROPS (K013204)Ciba Vision Corporation2002-04-03
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND (K014162)Lobob Laboratories, Inc.2002-01-15
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES (K011456)Sauflon Pharmaceuticals, Ltd.2001-07-17
MENICON PROGENT REMOVER (K002140)Menicon Co, Ltd.2000-10-10
LIPIDURE REWETTING DROPS (K000975)Nof Corp.2000-09-25
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION (K001964)Lobob Laboratories, Inc.2000-07-18
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 (K001235)Alcon Universal, Ltd.2000-07-03
OPTIMUM WETTING AND REWETTING DROP (K001428)Lobob Laboratories, Inc.2000-05-26
SOLO-CARE BRAND HARD SOLUTION (K000607)Ciba Vision Corporation2000-05-15
OPTI-FREE EXPRESS LENS DROPS (K000385)Alcon Universal, Ltd.2000-04-28
RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148)Alcon Laboratories2000-04-11
HYLASHIELD CL (K994170)Biomatrix, Inc.2000-03-02
SOLO-CARE BRAND HARD SOLUTION (K993949)Ciba Vision Corporation2000-01-05
RIGID GAS PERMEABLE CONTACT LENS SOLUTION (K983836)Polymer Technology Div. Wilmington Partners, L.P.1999-02-11
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION (K983291)Ciba Vision Corporation1998-11-25
BOSTON ADVANCE CLEANER (K974466)Polymer Technology Corp.1998-02-19

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