Etherea MX

Powered Laser Surgical Instrument

Vydence Medical Industria E Comercio Ltda

The following data is part of a premarket notification filed by Vydence Medical Industria E Comercio Ltda with the FDA for Etherea Mx.

Pre-market Notification Details

• Device ID: K171443
• 510k Number: K171443
• Device Name: Etherea MX
• Classification: Powered Laser Surgical Instrument
• Applicant: Vydence Medical Industria E Comercio Ltda Rua Aldo Germano Klein, 359 Cep: 13.573-470 - Caixa Postal 772 Ceat - Sao Carlos/sp Sao Paulo, BR 13.573-470
• Contact: Kathy Maynor
• Correspondent: Kathy Maynor; Kathy Maynor 26 Rebecca Ct Homosassa, FL 34446
• Product Code: GEX
• Subsequent Product Code: ILY
• Subsequent Product Code: ONF
• Subsequent Product Code: PDZ
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-16
• Decision Date: 2018-04-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07898961835075	K171443	000