Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012918760

FEI Number

3012918760

Entity Name

JOOWON INNOVATION CO., LTD.

City/State/Country

Cheonan-si, Seobuk-gu Chungnam, KR

Establishment Address

44, Sureteo 1-gil, Cheonan-si, Seobuk-gu Chungnam 31074, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Joowon Innovation Co., Ltd. (Owner Number: 10052639)

Owner / Operator Contact Address

44, Sureteo 1-gil, Cheonan-si, Seobuk-gu, KR-44 31074, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161098

PMA Number

N/A

All Registered Proprietary Names

MOON RISE FAWN BROWN LADIVA Moodnight Mood Gray ViVi Ring Beige MOON RISE DEW GRAY Big Some Brown LUSH It's Black ViVi 3con Brown ViVi Ring Pink Big Some Gray Allure Fairy Charm OLIVE Prism Maple Gray ViVi-Ring Gray Chuing Choco It's Choco Oxygen View AQUA O2 View Oxygen Eye Cinnamon Brown Moodnight Mood Brown Chuing Brown Chic Eye Maple Brown COMPLEX 3CON GRAY Fairy Charm HAZEL BEYOND EPIC EYE Eyecon SIESTA O2 Eye ViVi-Ring Choco Maxvue Hydrosoft Colourvue Chromaview Eyefx NE 1 ViVi-Ring Brown Chiic View Someday Choco Beyond Maxvue HydroHD Phantasee

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	2016-08-31
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-08-31

Official Correspondent

Minyoung Lee

US Agent Details

Bret Andre Business: EyeReg Consulting, Inc. Email: bandre@fdapproval.com Phone: (503) 3725226

Related Public Records

Same Entity

Joowon Innovation Co., Ltd.

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.

Similar Registrations

Registration Number	Establishment Name	Location
3013785060	CAMDEN PASSAGE	Collingwood Ontario, CA
3008585940	GEO MEDICAL CO., LTD	Buk-gu Gwangju, KR
3005994941	SOLOTICA INDUSTRIA E COMERCIO LTDA	Sao Paulo, BR
3012590738	EYEYON MEDICAL	Nes Ziona Central, IL
3025414414	SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012918760. Last updated year: 2026. Please use registration number 3012918760 when referencing this establishment in official correspondence.