Objectt Optik Company Limited
Registered establishment in Hong Kong, China. 8 device types.
Objectt Optik Company Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Papers, Ion, Frame, Spectacle and 6 other device types. Its earliest product listing with the FDA dates from 1983.
Registration
| Registered name | OBJECTT OPTIK COMPANY LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 8040277 |
| FEI number | 3005939549 |
| Establishment type | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Hong Kong |
|---|---|
| Province | Hong Kong |
| Address | FLAT C, 5/F., HOP SHI FACTORY BUILDING, |
| Postal code | — |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Disinfectant, Medical Devices | Class 1 | Progear Anti FOG Lens Cleaning Wipe | 2020 | 197 |
| Frame, Spectacle | Class 1 | E-Optician, Progear, Free Form Green | 1983 | 430 |
| Lens, Contact, (Disposable) | Class 2 | Contact Lens | 2020 | 4 |
| Lens, Spectacle, Non-Custom (Prescription) | Class 1 | Progear, E-Optician, Free Form Green | 2011 | 263 |
| Lenses, Soft Contact, Daily Wear | Class 2 | Contact Lens | 2020 | 5 |
| Lenses, Soft Contact, Extended Wear | Class 3 | Contact Lens | 2020 | 2 |
| Papers, Ion | Class 1 | Progear Anti FOG GEL | 2020 | 6 |
| Sunglasses (Non-Prescription Including Photosensitive) | Class 1 | Rapala, E-Optician, Progear, Free Form Green | 1983 | 522 |
Clearances
No clearance names Objectt Optik Company Limited as applicant. 13 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K181796 | 2018-08-03 | LPL | Special | Alcon Laboratories, Inc. |
| K160803 | 2016-07-13 | LPL | Traditional | CooperVision, Inc. |
| K160212 | 2016-03-28 | LPL | Traditional | Johnson & Johnson Vision Care, Inc. |
| K131208 | 2013-09-11 | LPL | Traditional | Bausch & Lomb Incorporated |
| K113703 | 2012-06-05 | LPL | Traditional | Bausch & Lomb Incorporated |
| K091339 | 2010-01-05 | LPL | Traditional | CooperVision, Inc. |
| K073485 | 2008-03-03 | LPL | Traditional | Johnson & Johnson Vision Care, Inc. |
| K061948 | 2006-11-22 | MVN | Traditional | CooperVision, Inc. |
| K062614 | 2006-11-01 | LPL | Special | Johnson & Johnson Vision Care, Inc. |
| K052560 | 2005-12-06 | LPL | Traditional | CooperVision, Inc. |
| K042275 | 2004-10-28 | LPL | Traditional | Vistakon |
| K013973 | 2002-02-26 | LPL | Traditional | Vistakon |
| K000384 | 2000-03-06 | LPL | Special | CooperVision, Inc. |
PMA Approvals
A premarket approval is the Class III route: granted on clinical evidence, not on equivalence to a device already on the market.
| PMA number | Decision | Trade name | Product code | Held by |
|---|---|---|---|---|
| P040045 | 2013-02-27 | VISTAKON (SENOFILCON A) | LPM | Vistakon, Division of Johnson & Johnson Vision Car |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.