Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044710860

FEI Number

3044710860

Entity Name

OPTIKAL (SOUTHGATE) LTD

City/State/Country

BOREHAMWOOD, GB

Establishment Address

21 BULLHEAD ROAD, BOREHAMWOOD WD6 1HW, GB

Establishment Type(s)

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

Owner / Operator

OPTIKAL (SOUTHGATE) LTD (Owner Number: 10095708)

Owner / Operator Contact Address

21 BULLHEAD ROAD, BOREHAMWOOD, GB-NOTA WD6 1HW, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042275

PMA Number

N/A

All Registered Proprietary Names

Dailies AquaComfort Plus Toric 30pk Dailies AquaComfort Plus Multifocal 30pk Dailies AquaComfort Plus 30pk Dailies AquaComfort Plus Multifocal 90pk Dailies AquaComfort Plus 90pk Dailies AquaComfort Plus Toric 90pk Acuvue 2 Dailies Total1 for Astigmatism 30pk Dailies Total1 Multifocal 90pk Dailies Total1 Multifocal 30pk Dailies Total1 90pk Dailies Total1 6pk Dailies Total1 30pk Precision1 for Astigmatism 90pk Precision1 90pk Precision1 for Astigmatism 30pk Precision1 30pk Acuvue Oasys 1-Day for Astigmatism 90pk Acuvue Oasys 1-Day 30pk Acuvue Oasys Multifocal 6pk Acuvue Oasys Max 30pk Acuvue Oasys 24pk Acuvue Oasys 1-Day 90pk Acuvue Oasys 12pk Acuvue Oasys Max Multifocal 30pk Acuvue Oasys 1-Day for Astigmatism 30pk Acuvue Oasys for Astigmatism 6pk Acuvue Oasys Max Multifocal 90pk Acuvue Oasys 6pk Acuvue Oasys Max 90pk

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2026-04-21
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2026-04-21
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2026-04-16
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2026-04-16
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2026-04-16
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2026-04-21
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2026-04-21
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2026-04-16
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2026-04-16

Official Correspondent

No official correspondent registered.

US Agent Details

MANOJ ZACHARIAS Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

OPTIKAL (SOUTHGATE) 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.

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3043022738	METI OPTICAL INC	Dover, DE, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044710860. Last updated year: 2026. Please use registration number 3044710860 when referencing this establishment in official correspondence.