Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2241997

FEI Number

1000122339

Entity Name

SAFILO USA, INC.

City/State/Country

Secaucus, NJ, US

Establishment Address

300 Lighting Way, Suite 400, Secaucus, NJ 07094, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SAFILO USA (Owner Number: 2241997)

Owner / Operator Contact Address

22905 E. 19TH AVE, UNIT 120, Aurora, CO 80019, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Polaroid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2017-02-24

Official Correspondent

Joe Rubio

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SAFILO USA

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2241997. Last updated year: 2026. Please use registration number 2241997 when referencing this establishment in official correspondence.