Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004146030

FEI Number

3004146030

Entity Name

INTEROJO INC.

City/State/Country

PYONGTAEK-CITY Gyeonggi, KR

Establishment Address

28& 25 Sandan-ro 15 beon-gil, PYONGTAEK-CITY Gyeonggi --, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INTEROJO INC. (Owner Number: 9058386)

Owner / Operator Contact Address

28 & 25 Sandan-ro 15beon-gil, --, PYONGTAEK-CITY, KYONGGI-DO, KR-NOTA 459040, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K260507

PMA Number

N/A

All Registered Proprietary Names

Bella Color Toric Hydrogel Daily (Methafilcon) Contact Lenses BELLA ONE DAY COLOR (Methafilcon) Contact Lenses Clalen Iris Bella One Day Color Lenses Celena Dailies Hapa Kristin Contact Lenses, Hapa Kristin Contacts Hapa Kristin Colored Lenses, Hapa Kristin Lenses NANODOTS Hapa Kristin Colored Contact Lenses, Hapa Kristin Colored Contacts moody Comfort Colors Aquacolor Premium Monthly Contact Lens Crystal Vision Morning 55 Onya DYE-Dress Your Eyes (Oneday Color Contact Lenses) (Methafilcon) Aqualens Dailies Disposable Contact Lens Aquacolor Dailies Contact Lens PolyVue HD2 PolyVue HDX2 HDT PV PVT HD PolyVue HD Dailies Clalen Crystal Vision Bio 55 Apheric-55% contact lens Crystal Vision Oasys Toric-55% contact lens Clear Vision Daily Lens (Hioxifilcon) Contact Lenses acme 55 toric contact lens acme 55 aspheric contact lens BELLA ELITE (Polymacon) Contact Lenses Miz Toric-38% contact lens acme 42 aspheric contact lens Playful Kristin Impressions Hapa Kristin Contacts Hapa Kristin Colored Contact Lenses Hapa Kristin Lenses acme 42 toric contact lens PolyVue DW Aspheric-38% contact lens Hapa Kristin Contact Lenses Aquarella DYE-Dress Your Eyes (Monthly Color Contact Lenses) (Polymacon) Crystal Vision Color Crystal Vision Halloween Bella Color Monthly Hydrogel (Polymacon) Contact Lenses BELLA DIAMOND (Polymacon) Contact Lenses Bella Party Lens POLYMACON Soft hydrophilic lens for daily wear Crystal Vision Season BELLA GLOW (Polymacon) Contact Lenses Hapa Kristin Colored Contacts BELLA CONTOUR (Polymacon) Contact Lenses Hapa Kristin Colored Lenses BELLA HIGHLIGHT (Polymacon) Contact Lenses BELLA SNOW WHITE (Polymacon) Contact Lenses Iris On Vacation Kristin Soft Haze Kristin BELLA NATURAL (Polymacon) Contact Lenses Aquarella PolyVue Impressions Iris SiHy 45% Dk 70 Monthly Interojo 45

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2015-03-16
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2015-03-16
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2010-08-10
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2008-03-29
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-07-06
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-07-06
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2023-08-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2008-03-29
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2026-06-01

Official Correspondent

No official correspondent registered.

US Agent Details

BRET ANDRE Business: EYEREG CONSULTING, INC. Email: bandre@fdapproval.com Phone: (503) 3725226

Related Public Records

Same Entity

INTEROJO INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133079	Alden Optical Labs., Inc.	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)	2013-12-17
K941998	Ocu-Ease Optical Products, Inc.	OCU-FLEX-38 (POLYMACON)	1994-10-13
K992500	Cantor & Silver , Ltd.	CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS	1999-08-18
K984098	Adventures IN Color Technology, Ltd.	ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS	1999-05-10
K003161	Les Laboratoires Blanchard	ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT	2000-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses
Z-0044-2012	CooperVision Inc.	2	AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Z-0326-2026	Alcon Research LLC	2	Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004146030. Last updated year: 2026. Please use registration number 3004146030 when referencing this establishment in official correspondence.