Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010640396

FEI Number

3010640396

Entity Name

KELABIT S.R.O.

City/State/Country

Ostrava Moravskoslezsky Kraj, CZ

Establishment Address

Na Mlynici 13, Ostrava Moravskoslezsky Kraj 7200, CZ

Establishment Type(s)

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

Owner / Operator

Kelabit s.r.o. (Owner Number: 10051198)

Owner / Operator Contact Address

Na Mlynici 13, Privoz, CZ-806 702 00, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123202

PMA Number

N/A

All Registered Proprietary Names

MY DAY DW 90 PACK COOPERVISION Total30 Precision 1 BALAFILCON A - Contact Lens AVAIRA VITALITY ACUVUE VITA 6 PACK DW Clarity 1 Day for Atigmatism ULTRA PureVision 2HD AIR OPTIX plus HydraGlyde Acuvue Oasys MAX 1 Day

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-15
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-12-20
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-12-20
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-05-17
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-05-17
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2021-08-23
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2021-08-23
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-07-08
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-12-20
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-12-20
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-12-20
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-02-15
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-12-20
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-12-20
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-12-20
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-12-20
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-12-20
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-12-20
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2016-02-18
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2017-01-03
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2025-12-02
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2025-12-02
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2016-02-18
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-02-18
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-02-18

Official Correspondent

Tomas Sotak

US Agent Details

MIROSLAVA BRACH Email: brach4art@gmail.com Phone: (732) 8181751

Related Public Records

Same Entity

Kelabit s.r.o.

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

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3043022738	METI OPTICAL INC	Dover, DE, US
3012760082	Maxvue Vision Sdn. Bhd.	Seremban Negeri Sembilan, MY
3026035637	Innova Vision Inc.	Hsinchu City, Hsinchu (City), TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010640396. Last updated year: 2026. Please use registration number 3010640396 when referencing this establishment in official correspondence.