Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020659203

FEI Number

3020659203

Entity Name

Passiflora inc.

City/State/Country

Miami Beach, FL, US

Establishment Address

Passiflora Inc., 1000 5th Street Suite 200, Miami Beach, FL 33139, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Passiflora Inc (Owner Number: 10061598)

Owner / Operator Contact Address

Passiflora Inc., 1000 5th Street Suite 200, Miami Beach, FL 33139, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182774

PMA Number

N/A

All Registered Proprietary Names

In2 Patch Tripollar Device Zutta LED Mask Tripollar Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRC	Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation	Gastroenterology, Urology	Class 2	876.5026	2024-12-04
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2021-06-04
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2022-01-14
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2022-01-14
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2022-01-14
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2019-10-31

Official Correspondent

Moran Tabak

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Passiflora 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 3020659203. Last updated year: 2026. Please use registration number 3020659203 when referencing this establishment in official correspondence.