ScleralEase
All-in-One Scleral Lens Application and Removal Tool
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | ODC Industries, France |
|---|---|
| FDA product code | KYE |
| Device type | Inserter/Remover Contact Lens |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5420 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-02-21 |
| Record revised | 2026-03-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4044 SCLE-1 | In distribution | ||
| 4045 SCLE-4 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| DMV Classic | 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.