ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI.

FDA Device Registration & Listing · FATIH Istanbul, TR · Registration 3036689755

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
3036689755
FEI Number
3036689755
Entity Name
ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI.
City/State/Country
FATIH Istanbul, TR
Establishment Address
HOBYAR MAH. KASTELLI IS MERKEZI, FATIH Istanbul 34112, TR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI. (Owner Number: 10092704)
Owner / Operator Contact Address
HOBYAR MAH. KASTELLI IS MERKEZI, FATIH, TR-34 34112, TR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K210930
PMA Number
N/A

All Registered Proprietary Names

DAILIES TOTAL1, DAILIES TOTAL1 Asphere DAILIES TOTAL1 Multifocal Toric DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal Biotrue ONEday for Astigmatism with NaturMoist Biotrue ONEday for Presbyopia with NaturMoist BIOTRUE ONE DAY (NESOFILCON A) Soft Contact Lenses Biotrue ONEday with NaturMoist PROCLEAR 1DAY, PROCLEAR XC PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL Bausch + Lomb (kalifilcon A Bausch + Lomb (kalifilcon A) for Astigmatism Bausch + Lomb (kalifilcon A) for Presbyopia Acuvue 2; Acuvue Oasys Max 1-Day ACUVUE OASYS MAX 1-Day MULTIFOCAL 1 Day Acuvue Define; 1 Day Acuvue Moist 1 Day Acuvue Moist For Astigmatism ACUVUE OASYS with HydraLuxe Acuvue Oasys For Presbyopia Acuvue Oasys For Astigmatism ACUVUE OASYS 1-Day with HydraLuxe Acuvue Oasys Multifocal PROCLEAR 1DAY, PROCLEAR XC PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL PUREVISION 2; PureVision 2 for Astigmatism; PureVision 2 for Presbyopia Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS ACUVUE® VITA 12 pack ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens for ASTIGMATISM ACUVUE® VITA 6 pack Bausch + Lomb ULTRA Multifocal Toric Bausch + Lomb ULTRA Bausch + Lomb ULTRA for Astigmatism Bausch + Lomb ULTRA for Presbyopia Acuvue Oasys Max 1-day ACUVUE OASYS MAX 1-Day MULTIFOCAL ACUVUE OASYS MAX 1-Day ASTIGMATISM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2025-07-25
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-07-25
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2025-09-29
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-09-29
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2026-06-16
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2026-06-16
NJW Control Material, Her-2/Neu, Immunohistochemistry Hematology Class 2 864.1860 2025-12-03
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-02-07
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-02-07
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2025-02-07
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2026-06-16
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2026-06-16
LPM Lenses, Soft Contact, Extended Wear Ophthalmic Class 3 886.5925 2026-01-20
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2026-01-05
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2026-01-05
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2026-01-05
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-04-30
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2025-04-30
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-02-07
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2025-02-07
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2025-12-03
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2025-12-03

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

ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI.
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 3036689755. Last updated year: 2026. Please use registration number 3036689755 when referencing this establishment in official correspondence.
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