Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013124682

FEI Number

3013124682

Entity Name

GO PRO NOW LTD

City/State/Country

Hexham Northumberland, GB

Establishment Address

11 - 12 The Courtyard, St Marys Chare, Hexham Northumberland NE461NH, GB

Establishment Type(s)

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

Owner / Operator

Go Pro Now Ltd (Owner Number: 10056523)

Owner / Operator Contact Address

Business Centre, 43 Yaverland Drive, Bagshot, GB-SRY GU19 5DX, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123202

PMA Number

N/A

All Registered Proprietary Names

1-Day Acuvue Oasys with Hydraluxe; 1-Day Acuvue TruEye; Acuvue 2; Acuvue Oasys; Acuvue Oasys for Astigmatism; Acuvue Oasys for Presbyopia Soflens 38; Soflens Multifocal ACUVUE® OASYS MAX 1-DAY Contact Lenses VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER TRUEYE Clariti 1 Day Daily Disposable Contact Lens Proclear Contact Lenses Frequency 55 Biofinity Energys DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC Soflens Daily Disposable Contact Lens BIOTRUE BAUSCH + LOMB NESOFILCON A CONTACT LENS PUREVISION Purevision 2 for Astigmatism HD; PureVision 2 HD; Purevision 2 Multi-Focal for Presbyopia; Purevision Toric Sunglasses (Non-Prescription Including Photosensitive) ACUVUE VITA (Senofilcon C) Soft Contact Lens BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, Acuvue One day Moist BIOMEDICS EVOLUTION (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS 1 Day Acuvue Define 30 Pack; 1 Day Acuvue Define 90 Pack; 1 Day Acuvue Moist 30 Pack; 1 Day Acuvue Moist 90 Pack; 1 Day PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS

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	2022-04-22
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-07-10
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-07-10
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-20
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-20
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2022-04-25
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-22
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-25
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-25
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2021-01-28
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-25
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-25
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-25
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-04-25
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-04-25

Official Correspondent

James Weston Weston

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Go Pro Now 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013124682. Last updated year: 2026. Please use registration number 3013124682 when referencing this establishment in official correspondence.