510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K212399Substantially Equivalent

Aveli

Nc8, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212399 is the FDA 510(k) clearance record for Aveli, a class II device, cleared for Nc8, Inc. on under FDA product code OUP (Powered Surgical Instrument For Improvement In The Appearance Of Cellulite). FDA's definition for product code OUP reads: "Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite". FDA records list one 510(k) clearance for Nc8, Inc. As of , FDA records show no recalls naming K212399.

Clearance record

Decision date
Received
(81 days to decision)
Product code
OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Regulation
21 CFR 878.4790
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Nc8, Inc. 2570 W. El Camino Real, Suite 310, Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUP

Trailing 12 months

FDA records hold no clearances under product code OUP in the trailing twelve months.

FDA records show no clearances under product code OUP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260