Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016248648

FEI Number

3016248648

Entity Name

OFTAL-ONE INC

City/State/Country

Coral Gables, FL, US

Establishment Address

250 Catalonia Ave, Suite 506, Coral Gables, FL 33134, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Oftal-One Inc (Owner Number: 10062156)

Owner / Operator Contact Address

250 Catalonia Ave, Suite 506, Coral Gables, FL 33134, 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
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-05-13

Official Correspondent

Elena Morozova

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Oftal-One Inc

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 3016248648. Last updated year: 2026. Please use registration number 3016248648 when referencing this establishment in official correspondence.