FDA Product Code OUP: Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Used For Controlled Release Of Subcutaneous Tissue For Improvement In The Appearance Of Cellulite.
Leading manufacturers include Revelle Aesthetics, Inc. and Nc8, Inc..
9
Total
8
Cleared
143d
Avg days
2013
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Powered Surgical Instrument For Improvement In The Appearance Of Cellulite Devices (Product Code OUP)
9 devices
Cleared
Aug 18, 2023
Avéli
Revelle Aesthetics, Inc.
General & Plastic Surgery
30d
Cleared
Aug 05, 2022
Avéli
Revelle Aesthetics, Inc.
General & Plastic Surgery
88d
Cleared
Oct 22, 2021
Aveli
Nc8, Inc.
General & Plastic Surgery
81d
About Product Code OUP - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code OUP since 2013, with 8 receiving FDA clearance (average review time: 143 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
OUP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →