Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012546757

FEI Number

3012546757

Entity Name

BOLD VISION GROUP LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

Room 1303, 13/F, Multifield Commercial Centre, 426 Shanghai Street, Mongkok, Hong Kong 00000, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Bold Vision Group Limited (Owner Number: 10052103)

Owner / Operator Contact Address

Room 1303, 13/F, Multifield Commercial Centre, 426 Shanghai Street, Mongkok, Hong Kong, HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123202

PMA Number

N/A

All Registered Proprietary Names

VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) VISTAKON (SENOFILCON A) SOFT CONTACT LENS BioTrue 1 Day Sphere PROCLEAR 1 DAY 90 PACK

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	2020-11-18
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2020-11-18
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2016-06-14
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2016-06-14
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2018-11-21
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2019-03-15
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2019-03-15
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-06-07
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2020-11-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2020-11-18
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-06-14
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-06-14
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2020-11-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2020-11-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2017-11-29
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2017-11-29
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2017-11-29
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2020-11-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2020-11-18

Official Correspondent

Mika Viljakainen

US Agent Details

Larry Ordet Business: FDA Solutions Group LLC Email: info@fdasolutionsgroup.com Phone: (305) 7023161

Related Public Records

Same Entity

Bold Vision Group Limited

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 3012546757. Last updated year: 2026. Please use registration number 3012546757 when referencing this establishment in official correspondence.