Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009492367

FEI Number

3009492367

Entity Name

THEMA USA LLC

City/State/Country

Miami, FL, US

Establishment Address

1900 NW 133rd Avenue, Unit 1, Miami, FL 33182, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Thema USA LLC (Owner Number: 10040089)

Owner / Operator Contact Address

1900 NW 133rd Ave, Unit 1, Miami, FL 33182, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2012-03-07

Official Correspondent

Oscar Bettello

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thema USA LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009492367. Last updated year: 2026. Please use registration number 3009492367 when referencing this establishment in official correspondence.