FreshKon® 1-Day (Etafilcon A)

10 sterile one day disposable daily wear soft contact lenses, 42% etafilcon A, 58% water, immersed in 0.9% buffered saline. Indication for Use:The FreshKon® Contact Lens is indicated for…

Registry build 21.09.26

10 sterile one day disposable daily wear soft contact lenses, 42% etafilcon A, 58% water, immersed in 0.9% buffered saline. Indication for Use:The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye. The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.

4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Hong Kong (2), Hunan (1), Guangdong (1).

Chinese manufacturers registered for FDA product code MVN
Manufacturer City Province Registered as Device types
Objectt Optik Company Limited Hong Kong Hong Kong Contract manufacturer 8
Bloom MAX Limited Central Hong Kong Manufacturer 3
Hunan Haipuming Technology Co., Ltd. Shaoyang Hunan Manufacturer 2
Shenzhen Dashicheng Optical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for FreshKon® 1-Day (Etafilcon A)
Listed by Oculus, Inc., United States
FDA product code MVN
Device type Lens, Contact, (Disposable)
Device class Class 2
Regulation 21 CFR 886.5925
Establishment Complaint-file establishment
Record published 2016-09-15
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Sizes Outer diameter 14.2 mm

Catalogue Numbers

Catalogue numbers for FreshKon® 1-Day (Etafilcon A)
Catalogue number Size Per pack Status
Alluring Eye,Mosaic,Colors Fusion Outer Diameter 14.20 mm 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ZonedIn Contact Lenses Zonedin Vision LLC 215
Qualis Unicon Optical Co., Ltd. 117
ZonedIn Vision Contact Lenses Zonedin Vision LLC 66
Ideal SiHy/1Day/30PK Vizionfocus Inc. 55
Aveo Hello Supervision Optimax SDN BHD 53
ProOcular Daily Disposable Contact Lens Carlsbad Technology Inc. 29
PolyVue HD Dailies Interojo Inc. 4

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer