Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006695864

FEI Number

3006695864

Entity Name

AMO Manufacturing USA, LLC

City/State/Country

Milpitas, CA, US

Establishment Address

510 Cottonwood Drive, Milpitas, CA 95035, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,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

K223566

PMA Number

N/A

All Registered Proprietary Names

Keratome, ac-powered Powered laser surgical instrument Keratome, ac-powered Powered laser surgical instrument Unit, phacofragmentation Unit, phacofragmentation Unit, phacofragmentation Gen3 LOI ELITA Femtosecond Laser System ELITA Patient Interface 1-pack ELITA Patient Interface 20-pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2021-03-15
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-12-22
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2016-12-22
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2019-06-26
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-12-22
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2017-06-15
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-10-24
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2020-06-16
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2021-11-15
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2017-09-15
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2022-06-10
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2023-04-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15
K111697	Abbott Medical Optics, Inc.	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	2011-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0046-2014	Abbott Medical Optics, Inc.	3	STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-0047-2014	Abbott Medical Optics, Inc.	3	STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-0048-2014	Abbott Medical Optics, Inc.	3	STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-0049-2014	Abbott Medical Optics, Inc.	3	STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Z-1515-2015	Abbott Medical Optics, Inc.	2	OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Z-1539-2013	Abbott Medical Optics, Inc.	3	STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Z-1540-2013	Abbott Medical Optics, Inc.	3	STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Z-1541-2013	Abbott Medical Optics, Inc.	3	STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006695864. Last updated year: 2026. Please use registration number 3006695864 when referencing this establishment in official correspondence.