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ART OPTICAL CONTACT LENS, INC.

USA · Walker

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 2Class II 3Class III 1unclassified 1

plus 37 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States37 registration records, 6 510(k), 0 PMA, 11 excluded

Brazil0 confirmed, 5 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: ART OPTICAL CONTACT LENS, INC. · ART CRAFT OPTICAL CO., INC.

FDA 510(k) clearances by year

12008 · K073621

12010 · K100221

22015 · K152046

12017 · K172314

12023 · K230824

FDA listed device types

Lens, Contact (Orthokeratology) 1Lenses, Soft Contact, Daily Wear 1Lens, Contact (Other Material) - Daily 1Lens, Contact (Rigid Gas Permeable), Extended Wear 1Lens, Contact (Polymethylmethacrylate) 1Sunglasses (Non-Prescription Including Photosensitive) 1Frame, Spectacle 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230824	IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)	2023-09-06
US	K172314	Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)	2017-09-20
US	K152046	Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)	2015-11-24

ART OPTICAL CONTACT LENS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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