Vial Assembly
Contact lens vial with cap and gasket/claw The finished assemblies can be made with variation in the color of the cap and the insertion of a gasket or a claw. Additionally, the claw has…
Contact lens vial with cap and gasket/claw The finished assemblies can be made with variation in the color of the cap and the insertion of a gasket or a claw. Additionally, the claw has three distinct sizes, Small (S), Large (L), and Extra Large (X).
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| China (Shenyang) MED-Land IMP/EXP Corp., Ltd. | Shanghai | Shanghai | Exporter | 32 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Action Eyewear Corp. | Dong Guan | Guangdong | Contract manufacturer | 5 |
| Ningbo Kaida Rubber AND Plastic Technology Co., Ltd. | Yu Yao City, Zhejiang Province | Contract manufacturer | 2 | |
| Danyang Chanxin Glasses Cases Factory | Danyang | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Paragon Vision Sciences, Inc., United States |
|---|---|
| FDA product code | LRX |
| Device type | Case, Contact Lens |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5928 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2017-12-08 |
| Record revised | 2021-03-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 900 | 1,000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optisource | Phoenix Medical Solutions | 18 |
| Bonasse | Bonasse Enterprises Co., Ltd. | 12 |
| Equate | Wal Mart Stores, Inc | 11 |
| Optego | Optego Vision USA, Inc. | 10 |
| UP & UP | Target Health, Inc. | 7 |
| Meijer | Meijer, Inc. | 6 |
| Flents | Apothecary Products, LLC. | 6 |
| Jingsheng | Ningbo Haishu Jingsheng Plastic Co., Ltd. | 4 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 4 |
| Apex | Drive DeVilbiss Healthcare | 3 |
| Color Case | Watchdog Group, LC | 3 |
| Phoenix Healthcare Solutions LLC | Phoenix Medical Solutions | 3 |
Showing 12 of 52. All products under Case, Contact Lens
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K993487 | 1999-12-22 |
| K993486 | 1999-12-22 |
| K974635 | 1998-02-04 |
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.