Aveli

Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

NC8, Inc.

The following data is part of a premarket notification filed by Nc8, Inc. with the FDA for Aveli.

Pre-market Notification Details

• Device ID: K212399
• 510k Number: K212399
• Device Name: Aveli
• Classification: Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
• Applicant: NC8, Inc. 2570W. El Camino Real, Suite 310 Mountain View, CA 94040
• Contact: Mellissa Viotti
• Correspondent: Mellissa Viotti; NC8, Inc. 2570W. El Camino Real, Suite 310 Mountain View, CA 94040
• Product Code: OUP
• CFR Regulation Number: 878.4790 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-02
• Decision Date: 2021-10-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850036790006	K212399	000
00850036790013	K212399	000