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Data / Medical devices / Inserter/Remover Contact Lens

Inserter/Remover Contact Lens (KYE): 14 FDA-registered makers in 7 countries

14 establishments in 7 countries are registered with the FDA to make Inserter/Remover Contact Lens (product code KYE, Class 1, 21 CFR 886.5420). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on August 10, 1987, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KYE
Device class
1
Regulation
886.5420
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States6
China3
Taiwan1
Pakistan1
Thailand1
Canada1
France1

Makers of Inserter/Remover Contact Lens

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
DMV CorporationZanesville, OH, United StatesManufacturer1March 9, 1983000api.fda.gov
Adventure In Colors, Inc.Golden, CO, United StatesManufacturer0000api.fda.gov
Bonasse Ent. Co., Ltd.CHUNGLI CITY Taoyuan, TaiwanManufacturer0000api.fda.gov
Dalsey Adaptives, LLC.Easthampton, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Dongguan Worldtop Technology Co.,ltdDongGuan City Guangdong, ChinaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Home Richfull Technology (thailand) Company LimitedBan Khai Rayong, ThailandManufacturer0000api.fda.gov
Ningbo Just Soon Industrial LimitedNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Kaida Rubber And Plastic Technology Co., LtdYu Yao City, Zhejiang Province, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Nomax, Inc.Affton, MO, United StatesManufacturer0000api.fda.gov
Oculo Plastik, Inc.MONTREAL Quebec, CanadaManufacturer0000api.fda.gov
Odc IndustriesPloermel Bretagne, FranceManufacturer0000api.fda.gov
Optodex, Inc.Salt Lake City, UT, United StatesSpecification developer0000api.fda.gov
Optego Vision USA, Inc.Tucson, AZ, United StatesManufacturer0000api.fda.gov

Updated August 10, 1987. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.