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OUP — Powered Surgical Instrument For Improvement In The Appearance Of Cellulite Class II

FDA Device Classification

Classification Details

Product Code
OUP
Device Class
Class II
Regulation Number
878.4790
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232153revelle aestheticsAvéliAugust 18, 2023
K221336revelle aestheticsAvéliAugust 5, 2022
K212399nc8AveliOctober 22, 2021
K192185ultheraThe Cellfina SystemOctober 9, 2019
K161885ultheraThe Cellfina SystemOctober 5, 2016
K153677ultheraThe Cellfina SystemFebruary 25, 2016
K150505ultheraCellfina SystemJuly 29, 2015
K134010cabochon aestheticsCABOCHON SYSTEMApril 14, 2014
DEN110004cabochon aestheticsCABOCHON SYSTEMJuly 12, 2013