Data / Medical devices / Brazil / Vydence Medical Industria e Comercio Ltda

Vydence Medical Industria e Comercio Ltda: FDA-registered device maker in CEAT - Sao Carlos/SP Sao Paulo, Brazil, 8 510(k) clearances

Name: Vydence Medical Industria e Comercio Ltda FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vydence Medical Industria e Comercio Ltda is registered with the FDA (registration 3007085226) in CEAT - Sao Carlos/SP Sao Paulo, Brazil. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 24, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007085226
Address: Rua Aldo Germano Klein, 359 CEP: 13. - Caixa Postal 772, CEAT - Sao Carlos/SP Sao Paulo, Brazil, 13.573-470
Owner or operator: Vydence Medical Industria e Comercio Ltda (10040501)
Roles: Complaint file establishment, Exporter to the US, Manufacturer
First device listed: April 20, 2012
Registered through: 2026
Brand names listed: 3-10 mm handpiece, 3-24, 5-15, 5-18 mm handpiece, 8-18 mm handpiece, Etherea, Etherea MX, HandPICO Fractional and more

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	PDZ	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Manufacturer	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
January 24, 2026	K252753	Vydence Family of Lasers	GEX	Substantially Equivalent	Vydence Medical Industria E Commercio Ltda	accessdata.fda.gov
December 20, 2024	K242534	HandPICO Fractional Laser Handpiece Tip	GEX	Substantially Equivalent	Vydence Medical	accessdata.fda.gov
May 5, 2022	K220041	HandPICO	GEX	Substantially Equivalent	Vydence Medical Industria E Comercio Ltda	accessdata.fda.gov
October 26, 2021	K202998	Vydence Zye and Vydence One	GEX	Substantially Equivalent	Vydence Medical Industria E Comercio Ltda	accessdata.fda.gov
March 1, 2019	K190007	Vydence Laser Family	GEX	Substantially Equivalent	Vydence Medical Industria E Comercio Ltda	accessdata.fda.gov
April 20, 2018	K171443	Etherea MX	GEX	Substantially Equivalent	Vydence Medical Industria E Comercio Ltda	accessdata.fda.gov
February 14, 2018	K172439	Siberian Fit	GEX	Substantially Equivalent	Vydence	accessdata.fda.gov
April 6, 2012	K112505	ETHEREA	GEX	Substantially Equivalent	Regulatory Insight, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 24, 2026. 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.