MENICON AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003515967	3003515967	MENICON AMERICA, INC.	1	Y	2026-01-01	76 Treble Cove Rd., Bldg. #3 North Billerica MA US 01862

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
11960	1245955788	P990018	MENICON Z RIGID GAS PERMEABLE CONTACT LENS	MWL	2000-07-11
11960	1215251565	K962006	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	HQD	1996-10-09
11960	2058937614	K262495	Miru 1day UpSide (midafilcon A)	LPL	2026-09-17
11960	1395198152	K193399	Miru 1day UpSide (midafilcon A)	LPL	2020-06-17
11960	1915712647	K180004	Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens	LPL	2018-02-22
11960	1742707862	K173136	Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses	MRC	2017-11-16
11960	1376085279	K151768	Menicon Saline Rinse Solution	LPN	2015-08-28
11960	1287979702	K130805	MENICON UNIQUE PH MULTI-PURPOSE SOLUTION	MRC	2013-07-03
11960	1999808229	K130285	PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS	LRX	2013-04-03
11960	1773975040	K122273	MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS	MRC	2013-01-02
11960	1690409348	K103561	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	HQD	2011-02-03
11960	1356557779	K081443	MENICON Z RIGID GAS PERMEABLE CONTACT LENS	HQD	2008-09-23

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LPL	4	2026-09-17
MRC	3	2017-11-16
HQD	3	2011-02-03
LPN	1	2015-08-28
LRX	1	2013-04-03
MWL	1	2000-07-11