Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016232028

FEI Number

3016232028

Entity Name

LUMITHERA, INC.

City/State/Country

Fort Worth, TX, US

Establishment Address

6201 South Fwy, Fort Worth, TX 76134, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Alcon Laboratories, Inc. (Owner Number: 1610287)

Owner / Operator Contact Address

6201 South Freeway, Fort Worth, TX 76134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN230083

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SDE	Light Based Device For Dry Age-Related Macular Degeneration	Ophthalmic	Class 2	886.5520	2025-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alcon Laboratories, 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
3013497605	Alcon Research, LLC	Sinking Spring, PA, US
3003701944	OPTONOL, LTD	NEVE ILAN Central, IL
3006186389	CIBA VISION JOHOR SDN.BHD.,	GELANG PATAH, JOHOR DARUL TAKZIM, MY
3016075957	IVANTIS, INC.	Irvine, CA, US
1119421	Alcon Research, LLC	HUNTINGTON, WV, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016232028. Last updated year: 2026. Please use registration number 3016232028 when referencing this establishment in official correspondence.