Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004178847

FEI Number

3004178847

Entity Name

AMO (HANGZHOU) CO., LTD.

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

200, 4TH AVE. HZ E&T DVLP. ZONE, HANGZHOU Zhejiang 310018, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Johnson & Johnson Surgical Vision, Inc. (Owner Number: 10053607)

Owner / Operator Contact Address

31 Technology Dr., Suite 200, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032030

PMA Number

N/A

All Registered Proprietary Names

Accessories, soft lens products Case, Contact Lens Accessories, soft lens products Case, Contact Lens Accessories, soft lens products 9464X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2016-12-22

Official Correspondent

Rosanne Melikian

US Agent Details

Rosanne Melikian Business: Johnson & Johnson Vision Email: RegulatoryImplantsMailBox01@its.jnj.com Phone: (714) 3138856

Related Public Records

Same Entity

Johnson & Johnson Surgical Vision, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005675890	OptiMedica Corp.	Milpitas, CA, US
3004750704	AMO UPPSALA AB	UPPSALA, SE
3008169506	TearScience, Inc.	Milpitas, CA, US
3011714173	AMO (HANGZHOU PARK) WAREHOUSE	Hangzhou Zhejiang, CN
9614546	AMO GRONINGEN BV	GRONINGEN, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K093254	Abbott Medical Optics, Inc.	AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION	2010-09-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-05	Ciba Vision Corporation	2	SOLO-care Plus with Aqualube, Multi-purpose solution* AquaSoft (Private label), Multi-purpose solutionSterile**For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Z-0129-2011	Abbott Medical Optics Inc (AMO)	2	AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Z-0130-2011	Abbott Medical Optics Inc (AMO)	2	AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.
Z-0030-2022	Contamac Solutions, Inc.	2	Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

Similar Registrations

Registration Number	Establishment Name	Location
1643525	ALLERGAN SALES, LLC	WACO, TX, US
3003306559	GLOBAL PACKAGING SYSTEMS INC	Fort Worth, TX, US
3012236936	Johnson & Johnson Surgical Vision, Inc.	Irvine, CA, US
9617489	TAIWAN BIOTECH CO., LTD.	TAOYUAN, TW
1032500	Bausch & Lomb Incorporated	GREENVILLE, SC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004178847. Last updated year: 2026. Please use registration number 3004178847 when referencing this establishment in official correspondence.