DeviceClearance

Product code NUV— General, Plastic Surgery

SMOOTHSHAPES

Classification name
Massager, Vacuum, Light Induced Heating
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
20
First cleared
Most recent

FDA classification definition

“The device is intended to temporarily alter the appearance of cellulite”

— U.S. Food and Drug Administration, device classification record for product code NUV under 21 CFR 878.4810, via openFDA

Market context for product code NUV

FDA has cleared 20 devices under product code NUV between 2005 and 2026, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NUV

Recent clearances under product code NUV

Data sourced from openFDA. This site is unofficial and independent of the FDA.