Data / Medical devices / China / Amo (hangzhou) Co., Ltd.
Amo (hangzhou) Co., Ltd.: FDA-registered device maker in HANGZHOU Zhejiang, China, 5 510(k) clearances and 1 PMA approval
Amo (hangzhou) Co., Ltd. is registered with the FDA (registration 3004178847) in HANGZHOU Zhejiang, China. It lists 2 device types. The FDA files 5 510(k) clearances and 1 PMA approval under its listings, the newest dated September 15, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004178847
- Address
- 200, 4TH Ave. HZ E&t DVLP. Zone, HANGZHOU Zhejiang, China, 310018
- Owner or operator
- Johnson & Johnson Surgical Vision, Inc. (10053607)
- Roles
- Manufacturer
- First device listed
- December 22, 2016
- Registered through
- 2026
- Brand names listed
- 9464X, Accessories, soft lens products, Case, Contact Lens
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Soft Lens Products | LPN | 2 | Manufacturer | accessdata.fda.gov |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2010 | K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | LPN | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| October 19, 2004 | K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS | MRC | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| September 25, 2003 | K032030 | BLINK CL LUBRICANT EYE DROPS | LPN | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| February 20, 2002 | K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | LPN | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| December 18, 1998 | K984383 | ULTRACARE NEUTRALIZING TABLETS | LPN | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 8, 1987 | P850088 | OXYSEPT SYSTEM | LPN | 31 | July 3, 1997 | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Soft Lens Products
- All makers of Products, Contact Lens Care, Rigid Gas Permeable
Updated September 15, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.