Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004423487

FEI Number

3004423487

Entity Name

PROLLENIUM MEDICAL TECHNOLOGIES INC.

City/State/Country

Aurora Ontario, CA

Establishment Address

138 Industrial Pkwy N., Aurora Ontario L4G4C3, CA

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Prollenium Medical Technologies Inc. (Owner Number: 10055618)

Owner / Operator Contact Address

138 Industrial Pkwy N., Aurora, CA-ON L4G4C3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Revanesse Versa Revanesse Versa+ with Lidocaine Revanesse Versa+ with Lidocaine 1.2 mL Revanesse® Lips + with Lidocaine 1.2 mL Revanesse® Lips + with Lidocaine Revanesse® Versa 1.2 mL SoftFil® Precision SoftFil® EasyGuide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2017-08-23
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-05-01

Official Correspondent

Denis Vezina

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Prollenium Medical Technologies 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
3019585045	Prollenium Medical Technologies Inc.	Richmond Hill Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004423487. Last updated year: 2026. Please use registration number 3004423487 when referencing this establishment in official correspondence.