Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680540

FEI Number

1000426389

Entity Name

GELFLEX LABORATORIES

City/State/Country

PERTH Western Australia, AU

Establishment Address

52 MULGUL ROAD MALAGA, PERTH Western Australia 6090, AU

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

GELFLEX LABORATORIES (Owner Number: 9009649)

Owner / Operator Contact Address

52 Mulgul Road Malaga, Perth, AU-WA 6090, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K024003

PMA Number

N/A

All Registered Proprietary Names

Lumenis Synergy, Gelflex Gamma, Delta. Alpha

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-09-29
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2008-01-15
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2008-01-15

Official Correspondent

DAVID MASEL

US Agent Details

Bret Andre Business: EyeReg Consulting Inc Email: bandre@fdapproval.com Phone: (503) 3725226

Related Public Records

Same Entity

GELFLEX LABORATORIES

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
3014128876	LIDLIFT, LLC	West Valley City, UT, US
2522949	PRAIRIE PRODUCTS, INC.	DOVER, PA, US
3014937479	QUANTIGE INDUSTRY SDN BHD	Shah Alam Selangor, MY
3021343301	TAIZHOU YIZHAN OPTICAL GLASSES CO., LTD	Taizhou City Zhejiang, CN
3015005459	TAIZHOU BAILIAN GLASSES MANUFACTURING CO, LTD	Taizhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680540. Last updated year: 2026. Please use registration number 9680540 when referencing this establishment in official correspondence.