Medical Device Manufacturer · US , Washington , DC

Menicon Co, Ltd.

17 submissions · 17 cleared · Since 1994
17
Total
17
Cleared
0
Denied

Menicon Co, Ltd. — FDA 510(k) Submissions

Menicon Co, Ltd. has submitted 17 FDA 510(k) premarket notifications since 1994, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Products, Contact Lens Care, Rigid Gas Permeable, Lens, Contact (other Material) - Daily, Lenses, Soft Contact, Daily Wear, Accessories, Soft Lens Products . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Miru 1day UpSide (midafilcon A)
K193399 · LPL Lenses, Soft Contact,... · Ophthalmic
Jun 2020 194d
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
K191872 · LPN Accessories, Soft Lens... · Ophthalmic
Mar 2020 234d
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
K180819 · LPL Lenses, Soft Contact,... · Ophthalmic
May 2018 48d
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · LPL Lenses, Soft Contact,... · Ophthalmic
Feb 2018 51d
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
K173136 · MRC Products, Contact Lens... · Ophthalmic
Nov 2017 48d
Menicon Saline Rinse Solution
K151768 · LPN Accessories, Soft Lens... · Ophthalmic
Aug 2015 59d
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
K130805 · MRC Products, Contact Lens... · Ophthalmic
Jul 2013 100d
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
K122273 · MRC Products, Contact Lens... · Ophthalmic
Jan 2013 156d
ONE DAY FLAT PACK
K102895 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2011 210d
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K103561 · HQD Lens, Contact (other... · Ophthalmic
Feb 2011 59d
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K082855 · MRC Products, Contact Lens... · Ophthalmic
Mar 2010 526d
MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K081443 · HQD Lens, Contact (other... · Ophthalmic
Sep 2008 124d
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K020930 · MRC Products, Contact Lens... · Ophthalmic
May 2002 41d
MENICON PROGENT REMOVER
K002140 · MRC Products, Contact Lens... · Ophthalmic
Oct 2000 85d
MENICON SF-P
K000233 · HQD Lens, Contact (other... · Ophthalmic
May 2000 113d
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K962006 · HQD Lens, Contact (other... · Ophthalmic
Oct 1996 140d
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR
K943784 · HQD Lens, Contact (other... · Ophthalmic
Oct 1994 86d
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