AMO (Hangzhou) Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 2 device types.
AMO (Hangzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Accessories, Soft Lens Products, Products, Contact Lens Care, Rigid Gas Permeable. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | AMO (HANGZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004178847 |
| FEI number | 3004178847 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 眼力健（杭州）制药有限公司 |
|---|---|
| Unified social credit code | 913301006091681459 |
| Source | NMPA UDI database |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | 200, 4TH AVE. HZ E&T DVLP. ZONE |
| Postal code | 310018 |
| Country | China |
Group
AMO (Hangzhou) Co., Ltd. is one of 2 plants registered under Johnson & Johnson Surgical Vision, Inc..
| Plant | City | Device types |
|---|---|---|
| AMO (Hangzhou Park) Warehouse | Hangzhou | 1 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Soft Lens Products | Class 2 | Accessories, soft lens products, Case, Contact Lens, 9464X | 2016 | 2 |
| Products, Contact Lens Care, Rigid Gas Permeable | Class 2 | 9464X | 2016 | 1 |
Clearances
No clearance names AMO (Hangzhou) Co., Ltd. as applicant. 5 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 |
|---|---|---|---|---|
| K093254 | 2010-09-15 | LPN | Traditional | Abbott Medical Optics, Inc. |
| K040839 | 2004-10-19 | MRC | Abbreviated | Advanced Medical Optics, Inc. |
| K032030 | 2003-09-25 | LPN | Traditional | Advanced Medical Optics, Inc. |
| K014202 | 2002-02-20 | LPN | Traditional | Allergan |
| K984383 | 1998-12-18 | LPN | Special | Allergan |
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 |
|---|---|---|---|---|
| P850088 | 1991-03-21 | LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET | LPN | Advanced Medical Optics, Inc. |
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.