Data / Medical devices / Canada / Troka Canada Inc.

Troka Canada Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 8 510(k) clearances

Name: Troka Canada Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Troka Canada Inc. is registered with the FDA (registration 3030495752) in Mississauga Ontario, Canada. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 2, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030495752
Address: 1290 Aimco Blvd Unit A, Mississauga Ontario, Canada, L4W 1B2
Owner or operator: TROKA CANADA INC. (10090872)
Roles: Exporter to the US
First device listed: May 27, 2024
Registered through: 2026
Brand names listed: Epilaze, Futura Pro (US Specification), Micro needle, PicoLazer Laser system, Pix-E, Ultralight LED system, multiple platform, spectrum

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Fat Reducing Low Level Laser	OLI	2	Exporter to the US	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Exporter to the US	accessdata.fda.gov
Skin Resurfacing Rf Applicator	OUH	2	Exporter to the US	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 2, 2024	K233143	PiXel8-Reveal	GEX	Substantially Equivalent	Rohrer Aesthetics	accessdata.fda.gov
May 24, 2021	K210535	UltraLight LED System	GEX	Substantially Equivalent	Rohrer Aesthetics, LLC	accessdata.fda.gov
January 17, 2020	K192583	PicoLazer Laser System	GEX	Substantially Equivalent	Rohrer Aesthetics, LLC	accessdata.fda.gov
July 9, 2019	K191162	EpiLaze Multi-wavelength Laser	GEX	Substantially Equivalent	Rohrer Aesthetics, LLC	accessdata.fda.gov
July 13, 2018	K180654	PINXEL-RF system	GEI	Substantially Equivalent	Rohrer Aesthetics, LLC	accessdata.fda.gov
April 11, 2013	K123777	MULTILASER SYSTEM	GEX	Substantially Equivalent	Ultralight Laser Technologies, LLC	accessdata.fda.gov
December 14, 2012	K113018	APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM	GEX	Substantially Equivalent	BEIJING SYNTECH LASER CO., LTD.	accessdata.fda.gov
November 3, 2011	K102524	FUTURA	IMG	Substantially Equivalent	Dr. Oliver Wenker, M.D., M.B.A.	accessdata.fda.gov

Compare with other makers

Updated February 2, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.