ZonedIn Vision Contact Lenses
Daily wear soft contact lens -12.00 power 2 trials
4manufacturers in China registered for this device type
66catalogue numbers in this listing
Who Else Makes It
Concentrated in Hong Kong (2), Hunan (1), Guangdong (1).
| 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
| Listed by | Zonedin Vision LLC, United States |
|---|---|
| FDA product code | MVN |
| Device type | Lens, Contact, (Disposable) |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5925 |
| Establishment | Repacker / relabeller |
| 510(k) | K083288 |
| Record published | 2021-01-22 |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 077 | In distribution | |
| 026 | In distribution | |
| 075 | In distribution | |
| 042 | In distribution | |
| 008 | In distribution | |
| 096 | In distribution | |
| 053 | In distribution | |
| 015 | In distribution | |
| 018 | In distribution | |
| 107 | In distribution | |
| 034 | In distribution | |
| 017 | In distribution | |
| 016 | In distribution | |
| 085 | In distribution | |
| 005 | In distribution | |
| 082 | In distribution | |
| 022 | In distribution | |
| 038 | In distribution | |
| 028 | In distribution | |
| 065 | In distribution | |
| 100 | In distribution | |
| 039 | In distribution | |
| 084 | In distribution | |
| 101 | In distribution | |
| 010 | In distribution | |
| 089 | In distribution | |
| 020 | In distribution | |
| 062 | In distribution | |
| 064 | In distribution | |
| 012 | In distribution | |
| 013 | In distribution | |
| 092 | In distribution | |
| 051 | In distribution | |
| 098 | In distribution | |
| 104 | In distribution | |
| 103 | In distribution | |
| 076 | In distribution | |
| 036 | In distribution | |
| 041 | In distribution | |
| 002 | In distribution | |
| 025 | In distribution | |
| 087 | In distribution | |
| 105 | In distribution | |
| 097 | In distribution | |
| 021 | In distribution | |
| 048 | In distribution | |
| 068 | In distribution | |
| 045 | In distribution | |
| 054 | In distribution | |
| 029 | In distribution | |
| 063 | In distribution | |
| 027 | In distribution | |
| 093 | In distribution | |
| 011 | In distribution | |
| 009 | In distribution | |
| 044 | In distribution | |
| 056 | In distribution | |
| 055 | In distribution | |
| 030 | In distribution | |
| 095 | In distribution | |
| 074 | In distribution | |
| 014 | In distribution | |
| 060 | In distribution | |
| 059 | In distribution | |
| 050 | In distribution | |
| 003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ZonedIn Contact Lenses | Zonedin Vision LLC | 215 |
| Qualis | Unicon Optical Co., Ltd. | 117 |
| 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 |
| FreshKon® 1-Day (Etafilcon A) | Oculus, Inc. | 1 |
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.