Bloom MAX Limited
Registered establishment in Central, Hong Kong, China. 3 device types.
Bloom MAX Limited is a manufacturer holding a current FDA establishment registration. The registration covers Lens, Contact, (Disposable), Lenses, Soft Contact, Daily Wear and 1 other device type. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | BLOOM MAX LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3039590526 |
| FEI number | 3039590526 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Central |
|---|---|
| Province | Hong Kong |
| Address | 16/F, Amtel Building, 144-148 Des Voeux Road |
| Postal code | 000852 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | Class 2 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch +, Lomb Ultra One Day, Bausch + Lomb Ultra One Day Multifocal | 2025 | 4 |
| Lenses, Soft Contact, Daily Wear | Class 2 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch +, Lomb Ultra One Day, Bausch + Lomb Ultra One Day Multifocal | 2025 | 5 |
| Lenses, Soft Contact, Extended Wear | Class 3 | Air Optix plus HydraGlyde | 2026 | 2 |
Clearances
No clearance names Bloom MAX 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 |
|---|---|---|---|---|
| K200528 | 2020-06-02 | LPL | Traditional | Bausch & Lomb Incorporated |
| K182902 | 2018-12-11 | LPL | Traditional | Alcon Laboratories, Inc. |
| K160212 | 2016-03-28 | LPL | Traditional | Johnson & Johnson Vision Care, Inc. |
| K131208 | 2013-09-11 | LPL | Traditional | Bausch & Lomb Incorporated |
| K130331 | 2013-07-26 | MVN | Traditional | Sauflon Pharmaceuticals, Ltd. |
| K123994 | 2013-02-21 | LPL | Traditional | Ciba Vision Gmbh |
| K113703 | 2012-06-05 | LPL | Traditional | Bausch & Lomb Incorporated |
| K113168 | 2012-03-30 | LPL | Traditional | Ciba Vision Gmbh |
| K062614 | 2006-11-01 | LPL | Special | Johnson & Johnson Vision Care, Inc. |
| K061157 | 2006-06-22 | MVN | Special | Bausch & Lomb Incorporated |
| K052560 | 2005-12-06 | LPL | Traditional | CooperVision, Inc. |
| K042275 | 2004-10-28 | LPL | Traditional | Vistakon |
| K013973 | 2002-02-26 | LPL | Traditional | Vistakon |
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 |
|---|---|---|---|---|
| P010019 | 2018-03-02 | Lotrafilcon A Soft Contact Lenses for Extended Wear | LPM | Alcon Laboratories, Inc. |
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.