X-CEL SPECIALTY CONTACTS

FDA Device Registration & Listing · DULUTH, GA, US · Registration 1065845

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1065845
FEI Number
3003040707
Entity Name
X-CEL SPECIALTY CONTACTS
City/State/Country
DULUTH, GA, US
Establishment Address
2775 Premiere Pkwy Ste 600, DULUTH, GA 30097, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Walman Optical (Owner Number: 2125182)
Owner / Operator Contact Address
2775 Premiere Parkway Ste 600, Duluth, GA 30097, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Flex 3 Bi-Toric SCone MegaThin Bi-Toric Summit ContinuVu Front Toric Limbal American Standard Reverse Geo ContinuVu Plus PostGraft Aspheric TriCurve MVP Flexlens Aphakic Flexlens Sphere Flexlens Piggyback Flexlens Prism Sphere Flexlens Tricurve Keratoconus Flexlens PRS Flexlens Keratoconus Flexlens Adult Aphakic Flexlens Large Diameter Flexlens Large Diameter Thick Edge Westcon Horizon Adult Aphakic Flexlens Toric Westcon Horizon Aphakic Rose K2 Rose K2 PG Rose K2 IC Atlantis 3D Atlantis MF Titan LD Atlantis Spherical Apex Atlantis LD Pinnacle LD Starlens Pinnacle Atlantis TPC Atlantis FT Pinnacle IC Reverse Geometry Proplus Bifocal TriCurve EZEyes X-Cel Cone Front Toric Wave QuadraCurve Summit American Standard Bi-Toric Summit Solution Bifocal EasyFocus Plus Continu Vu MVP eJupiter Visions ContinuVu Plus Limbal Aspheric Post Lasik MegaThin Aspheric Periphery Flex 3 eJupiter Plus Infinity GP Visions Custom Bitoric ePerimeter SCone Read Rite Bifocal Arc-Seg CV-4 ProLook Rose K2 NC PostGraft Rose K2 XL Oblate Rose K2 XL Rose K RG5 Overnight Ortho-K Lens GOV Overnight Ortho-K Lens Arc-Seg S-10 Ideal Cone Spherical Pinnacle Continu Vu Bi-Toric Summit Apogee MegaThin Ful-Vue TriCurve Read Rite Bifocal Proplus Bifocal Summit Bitoric Post Lasik EZEyes Limbal Front Toric Infinity GP Aspheric American Standard Starlens PostGraft Solution Bifocal Flex 3 MVP EasyFocus Plus SCone ContinuVu Plus QuadraCurve Flexlens Prism Sphere Flexlens Sphere Flexlens Tricurve Keratoconus Westcon Horizon Adult Aphakic Flexlens PRS Westcon Horizon Prism Sphere Flexlens Keratoconus Westcon Westhin Toric Westcon Horizon Toric Westcon Horizon Progressive Westcon Horizon Bi-Con Westcon Horizon Aphakic Westcon Horizon Bi-Con Toric Flexlens Multifocal Westcon Horizon Progressive Toric Flexlens Piggyback Flexlens ARC Westcon Horizon Sphere Flexlens Aphakic Flexlens Toric Flexlens Adult Aphakic Proplus Bifocal Spherical Pinnacle Front Toric SCone QuadraCurve Starlens Arc-Seg MegaThin MVP Pinnacle IC Pinnacle LD Bi-Toric Summit Reverse Geometry Sphere Summit EasyFocus Plus PostGraft Bitoric Titan LD Read Rite Bifocal American Standard ContinuVu Plus Limbal TriCurve EZEyes Flex 3 Continu Vu Aspheric Post Lasik Flexlens Idealsoft Flexlens Idealsoft PS eJupiter Perimeter ePerimeter Semi-Scleral eJupiter Plus Jupiter Flexlens Prism Sphere Westcon Horizon Sphere Westcon Horizon Large Diameter Westcon Horizon Bi-Con Westcon Horizon Toric Westcon Horizon Bi-Con Toric Westcon Horizon Progressive Toric Westcon Horizon Progressive Flexlens Piggyback Westcon Horizon Prism Sphere Flexlens Sphere Westcon Westhin Toric Flexlens Toric Flexlens Aphakic Flexlens PRS Flexlens Tricurve Keratoconus Westcon Horizon Adult Aphakic Westcon Horizon Aphakic Flexlens Adult Aphakic Flexlens Keratoconus Flexlens Multifocal Horizon/Westhin 55-G Spherical Rev Geo TPC Rev Geo Sphere Rev Geo Front Toric Solution Bifocal Infinity GP TriCurve Pinnacle LD Read Rite Bifocal Continu Vu MegaThin ContinuVu Plus Front Toric Limbal Spherical Pinnacle CV-4 Aspheric Periphery SCone Bi-Toric Summit Post Lasik Proplus Bifocal Summit Aspheric Starlens American Standard PostGraft EZEyes Visions Custom Pinnacle IC EasyFocus Plus MVP QuadraCurve Reverse Geometry Flex 3 Visions Titan LD Apex X-Cel Cone Bitoric Arc-Seg ProPlus Bifocal ePerimeter Summit Front Toric Jupiter Plus MVP Spherical SCone Aspheric Post Lasik Read Rite Bifocal QuadraCurve PostGraft Arc-Seg ContinuVu Plus Limbal ProLook EasyFocus Plus American Standard TriCurve EZEyes eJupiter Bi-Toric Summit Flex 3 Bitoric Rose K Rose K2 PG Continu Vu MegaThin Rose K2 NC Rose K2 Rose K2 XL Rose K2 IC Rose K2 XL Oblate PostGraft Bi-Toric Bi-Toric Summit Post Lasik Aspheric QuadraCurve MegaThin ContinuVu Plus Summit TriCurve American Standard Limbal EZEyes Flex 3 Read Rite Bifocal EasyFocus Plus SCone MVP Bitoric Inside Toric Continu Vu MVP American Standard Aspheric X-Cel Cone Summit Read Rite Bifocal Proplus Bifocal Bi-Toric Summit Spherical EasyFocus Plus SCone Starlens Arc-Seg Front Toric Infinity GP ContinuVu Plus Pinnacle TriCurve EZEyes MegaThin Limbal Post Lasik Flex 3 PostGraft QuadraCurve Atlantis LD Spherical Atlantis TPC Pinnacle IC Pinnacle Atlantis Atlantis 3D Atlantis FT Atlantis MF Apex Pinnacle LD Titan LD Starlens X-Cel Thin Wave TriCurve REMLens Wave Rose K2 PG Rose K2 IC Rose K Atlantis Atlantis TPC Pinnacle Pinnacle LD Atlantis LD Spherical Atlantis 3D Atlantis MF Apex Pinnacle IC Atlantis FT Titan LD Visions Custom Starlens Reverse Geometry Wave Infinity GP Visions Aspheric Solution Bifocal Front Toric PostGraft Aspheric Periphery Limbal Continu Vu QuadraCurve X-Cel Cone Bi-Toric Summit Arc-Seg Post Lasik Summit Jupiter Plus eJupiter ePerimeter SCone ContinuVu Plus ProLook MVP American Standard Bitoric Proplus Bifocal CV-4 EasyFocus Plus MegaThin TriCurve EZEyes Flex 3 Read Rite Bifocal Rose K2 Rose K2 XL Rose K2 XL Oblate Rose K2 NC Rose K2 XL Oblate Rose K2 PG Pinnacle LD Atlantis FT Spherical Pinnacle Titan LD Atlantis X-Cel Thin Atlantis 3D Starlens Apex Atlantis LD Atlantis TPC Pinnacle IC Visions Atlantis MF Aspheric Periphery CV-4 X-Cel Cone Reverse Geometry eJupiter American Standard QuadraCurve Envision Arc-Seg Visions Custom ePerimeter Summit Bitoric Infinity GP Solution Bifocal Bi-Toric Summit Front Toric Read Rite Bifocal Wave PostGraft EZEyes MegaThin Continu Vu Post Lasik Flex 3 ProLook Limbal Essential Solutions EasyFocus Plus Proplus Bifocal Jupiter Plus MVP ContinuVu Plus Aspheric TriCurve Rose K SCone Rose K2 NC Rose K2 IC Rose K2 Rose K2 XL Flexlens Flexlens PRS Westcon Horizon Prism Sphere Westcon Horizon Bi-Con Westcon Horizon Sphere Westcon Horizon Bi-Con Toric Westcon Horizon Toric Westcon Horizon Progressive Westcon Westhin Toric Westcon Horizon Large Diameter Westcon Horizon Progressive Toric Flexlens Multifocal Westcon Horizon Sphere Westcon Horizon Bi-Con Toric Westcon Horizon Toric Flexlens PRS Flexlens Aphakic Flexlens Keratoconus Flexlens Prism Sphere Flexlens Piggyback Flexlens Adult Aphakic Flexlens Tricurve Keratoconus Flexlens Toric Flexlens Sphere Horizon 55 Bi-Con Rose K2 IC Rose K2 XL Oblate Rose K2 Rose K Pinnacle Titan LD Pinnacle LD Atlantis TPC Apex Atlantis LD Atlantis 3D Atlantis FT Atlantis MF Atlantis Pinnacle IC Starlens Spherical X-Cel Thin Proplus Bifocal Wave CV-4 MVP Solution Bifocal ePerimeter MegaThin Post Lasik PostGraft Summit eJupiter Plus Arc-Seg Infinity GP EZEyes American Standard TriCurve Visions Flex 3 QuadraCurve Bi-Toric Summit X-Cel Cone Aspheric Read Rite Bifocal Reverse Geometry EasyFocus Plus Aspheric Periphery Visions Custom Bitoric ContinuVu Plus Front Toric SCone Continu Vu ProLook eJupiter Rose K2 PG Rose K2 XL Limbal Rose K2 NC Horizon/Westhin 38 softblu (Polymacon) soft (Spherical and Toric) Westcon Westhin Toric Westcon Horizon Bi-Con Westcon Westhin Toric Westcon Horizon Sphere Westcon Horizon Prism Sphere Westcon Horizon Progressive Westcon Horizon Toric Westcon Horizon Progressive Toric Westcon Horizon Adult Aphakic Westcon Horizon Bi-Con Toric Westcon Horizon Aphakic SCone Summit EasyFocus Plus Bi-Toric ContinuVu Plus TriCurve Reverse Geo MVP MegaThin American Standard Flex 3 Aspheric Flexlens Aphakic Flexlens ARC Flexlens Piggyback Flexlens Sphere Westcon Horizon Bi-Con Flexlens Toric Westcon Horizon Prism Sphere Flexlens Multifocal Westcon Horizon Progressive Toric Westcon Horizon Sphere Flexlens Prism Sphere Flexlens PRS Flexlens Tricurve Keratoconus Flexlens Large Diameter Westcon Westhin Toric Flexlens Keratoconus Westcon Horizon Bi-Con Toric Westcon Horizon Toric Westcon Horizon Progressive Westcon Horizon Aphakic Westcon Horizon Adult Aphakic Flexlens Adult Aphakic Apex Spherical Continu Vu American Standard PostGraft Aspheric SCone Summit EZEyes Front Toric Bi-Toric Summit TriCurve Flex 3 Pinnacle Starlens MVP Arc-Seg Proplus Bifocal Pinnacle LD Infinity GP Post Lasik Bitoric Read Rite Bifocal QuadraCurve EasyFocus Plus ContinuVu Plus Limbal MegaThin Wave Bitoric EasyFocus Plus eJupiter ProLook Aspheric Bi-Toric Summit MVP EZEyes SCone Limbal X-Cel Cone Flex 3 TriCurve Arc-Seg Front Toric Continu Vu PostGraft Summit Read Rite Bifocal QuadraCurve ePerimeter ContinuVu Plus Spherical American Standard MegaThin Jupiter Plus Post Lasik Spherical Arc-Seg Limbal Proplus Bifocal Front Toric Bi-Toric Summit MVP EasyFocus Plus MegaThin Flex 3 PostGraft Bitoric Continu Vu Read Rite Bifocal Summit Pinnacle American Standard Ideal Cone Infinity GP TriCurve EZEyes QuadraCurve Aspheric Post Lasik Ful-Vue SCone ContinuVu Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2023-12-11
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2014-03-07
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2021-09-23
NUU Lens, Contact, Orthokeratology, Overnight Ophthalmic Class 3 886.5916 2026-05-01
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-02-12
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2022-09-30
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2024-09-24
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2022-12-19
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2007-11-15
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2023-12-11
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-12-02
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-12-02
MUW Lens, Contact (Orthokeratology) Ophthalmic Class 2 886.5916 2025-12-17
HPX Lens, Contact (Polymethylmethacrylate) Unknown Class U N/A 2023-12-11
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2016-07-26
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2023-11-30
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2022-12-06
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2007-11-19
NUU Lens, Contact, Orthokeratology, Overnight Ophthalmic Class 3 886.5916 2022-07-14
MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic Class 3 886.5916 2022-07-14
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2016-06-15
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-02-12
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2011-01-13
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2021-09-23
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2007-11-15
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-12-02
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-12-02
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2014-03-07
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-12-02
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-02-12
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2016-06-15
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2008-12-02
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2019-01-31
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2023-12-11
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2014-03-07
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2022-09-30
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2022-12-06
HQD Lens, Contact (Other Material) - Daily Ophthalmic Class 2 886.5916 2022-09-30
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-02-12

Official Correspondent

Hue Tang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Walman Optical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1642130 NOUVEAU EYEWEAR, INC. CARROLLTON, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K963512 Benz Research and Development Corp. BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL 1997-07-31
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

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 1065845. Last updated year: 2026. Please use registration number 1065845 when referencing this establishment in official correspondence.
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