DMV Luma Serter Plus
45 degree Inserter for large contact lenses to be used with a pen light. No suction
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), elsewhere (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Dongguan Worldtop Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 2 |
| Ningbo Kaida Rubber AND Plastic Technology Co., Ltd. | Yu Yao City, Zhejiang Province | Contract manufacturer | 2 |
Record
| Listed by | DMV Corporation, United States |
|---|---|
| FDA product code | KYE |
| Device type | Inserter/Remover Contact Lens |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5420 |
| Establishment | Manufacturer |
| 510(k) | K830496 |
| Record published | 2020-04-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 424 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ScleralEase | ODC Industries | 2 |
| Laser kit | Oculo Plastik, Inc. | 1 |
| DMV Traditional | DMV Corporation | 1 |
| Suction Cups (12 units) | Oculo Plastik, Inc. | 1 |
| Silicone Suction Cup (12 pk) | Gulden Ophthalmics | 1 |
| DMV Luma Serter | DMV Corporation | 1 |
| Hayden Medical | Hayden Medical Inc | 1 |
| Blue Silicone Suction Cups (100 units) | Oculo Plastik, Inc. | 1 |
| DMV Vented Scleral Cup | DMV Corporation | 1 |
| DMV Scleral Cup | DMV Corporation | 1 |
| Silicone Suction Cup (10pk) | Gulden Ophthalmics | 1 |
| DMV Soft Lens Handler | DMV Corporation | 1 |
Showing 12 of 18. All products under Inserter/Remover Contact Lens
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.