Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015430860

FEI Number

3015430860

Entity Name

HARLEIGH (MALAYSIA) SDN. BHD.

City/State/Country

Johor Bahru, MY

Establishment Address

No 4, Jalan Tahana,Tampoi Industrial Estate, Johor Bahru 80350, MY

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Harleigh (Malaysia) Sdn. Bhd. (Owner Number: 10060965)

Owner / Operator Contact Address

No 4, Jalan Tahana,Tampoi Industrial Estate, Johor Bahru, MY-01 80350, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133176

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2019-07-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2019-07-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2019-07-22
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2022-02-24
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2022-02-24
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2019-07-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Harleigh (Malaysia) Sdn. Bhd.

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
3025414414	SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
3008034930	VASSEN CO., LTD.	Pyeongtaek-si Gyeonggi, KR
3043022738	METI OPTICAL INC	Dover, DE, US
3012760082	Maxvue Vision Sdn. Bhd.	Seremban Negeri Sembilan, MY
3010640396	KELABIT S.R.O.	Ostrava Moravskoslezsky Kraj, CZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015430860. Last updated year: 2026. Please use registration number 3015430860 when referencing this establishment in official correspondence.