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Data / Medical devices / South Korea / Interojo Inc.

Interojo Inc.: FDA-registered device maker in PYONGTAEK-CITY Gyeonggi, South Korea, 7 510(k) clearances

Interojo Inc. is registered with the FDA (registration 3004146030) in PYONGTAEK-CITY Gyeonggi, South Korea. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 29, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3004146030
Address
28& 25 Sandan-ro 15 beon-gil, PYONGTAEK-CITY Gyeonggi, South Korea, --
Owner or operator
INTEROJO INC. (9058386)
Roles
Manufacturer
First device listed
March 29, 2008
Registered through
2026
Brand names listed
Apheric-55% contact lens, Aquacolor Dailies Contact Lens, Aquacolor Premium Monthly Contact Lens, Aqualens Dailies Disposable Contact Lens, Aquarella, BELLA CONTOUR (Polymacon) Contact Lenses, BELLA DIAMOND (Polymacon) Contact Lenses, BELLA ELITE (Polymacon) Contact Lenses and more

Devices it lists

DeviceProduct codeClassRoleSource
Lens, Contact, (Disposable)MVN2Manufactureraccessdata.fda.gov
Lenses, Soft Contact, Daily WearLPL2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 29, 2026K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusLPLSubstantially EquivalentINTEROJO, Inc.accessdata.fda.gov
October 4, 2022K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact LensLPLSubstantially EquivalentINTEROJO, Inc.accessdata.fda.gov
April 8, 2016K153766Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily WearLPLSubstantially EquivalentINTEROJO, Inc.accessdata.fda.gov
March 12, 2015K142766I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearLPLSubstantially EquivalentINTEROJO, Inc.accessdata.fda.gov
December 17, 2008K080794POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEARLPLSubstantially EquivalentPolyvue Distribution, Inc.accessdata.fda.gov
May 16, 2002K020608HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)LPLSubstantially EquivalentPoly Vue Technolgies, Inc.accessdata.fda.gov
November 20, 2001K013220HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)LPLSubstantially EquivalentPoly Vue Technolgies, Inc.accessdata.fda.gov

Compare with other makers

Updated May 29, 2026. 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.