Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006946962

FEI Number

3006946962

Entity Name

VISION SCIENCE CO., LTD.

City/State/Country

Daegu, KR

Establishment Address

37-38, Maeyeo-ro 1-gil, Dong-gu, Daegu 41059, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VISION SCIENCE CO., LTD. (Owner Number: 10046391)

Owner / Operator Contact Address

37-38, Maeyeo-ro 1-gil, Dong-gu, Daegu, KR-NOTA 41059, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161124

PMA Number

N/A

All Registered Proprietary Names

AMARA CONTACT LENS Amara Lens Barris Land Dimple Color Contact Lenses Ooptimus Hapa Kristin Contacts Hapa Kristin Lenses SWATI lenses Trick or Treat Kristin Debut Kristin Dimple Color Hapa Kristin Colored Contacts Hapa Kristin Colored Contact Lenses Hapa Kristin Colored Lenses Dimple Color Colour Lenses Lovesick Kristin One of a Kind Kristin Lucid Kristin Grrrr Kristin SWATI coloured lenses Hapa Kristin Contact Lenses Sophisticated Kristin Doll Nikita Day n' Night Kristin Another Me Kristin Eyereve Colors 1-day Attention-Plz Kristin Dimplecolor 1-day colour lenses Sweet Tooth Kristin

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	2016-11-04
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-11-04

Official Correspondent

Jin Su Hwang

US Agent Details

BRET ANDRE Business: EYEREG CONSULTING INC. Email: BANDRE@FDAPPROVAL.COM Phone: (503) 3332246

Related Public Records

Same Entity

VISION SCIENCE 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

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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 3006946962. Last updated year: 2026. Please use registration number 3006946962 when referencing this establishment in official correspondence.