OptiMedica Corp.

FDA Device Registration & Listing · Milpitas, CA, US · Registration 3005675890

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005675890
FEI Number
3005675890
Entity Name
OptiMedica Corp.
City/State/Country
Milpitas, CA, US
Establishment Address
510 Cottonwood Dr, 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
N
Expiration Date (Year)
2026
510(k) Number
K161455
PMA Number
N/A

All Registered Proprietary Names

Ophthalmic femtosecond laser Ophthalmic Femtosecond Laser Ophthalmic femtosecond laser

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OOE Ophthalmic Femtosecond Laser Ophthalmic Class 2 886.4390 2016-12-22
OOE Ophthalmic Femtosecond Laser Ophthalmic Class 2 886.4390 2016-12-22
OOE Ophthalmic Femtosecond Laser Ophthalmic Class 2 886.4390 2016-12-22

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
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
3004178847 AMO (HANGZHOU) CO., LTD. HANGZHOU Zhejiang, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K170322 Abbott Medical Optics, Inc. Catalys Precision Laser System 2017-05-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005675890. Last updated year: 2026. Please use registration number 3005675890 when referencing this establishment in official correspondence.
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