FDA Product Code NUV: Massager, Vacuum, Light Induced Heating
The Device Is Intended To Temporarily Alter The Appearance Of Cellulite
Leading manufacturers include I-Tech Industries Srl and B&M S.R.L. Marketing Nel Benessere.
19
Total
19
Cleared
113d
Avg days
2005
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Massager, Vacuum, Light Induced Heating Devices (Product Code NUV)
19 devices
Cleared
Sep 22, 2023
T-SHAPE 2
B&M S.R.L. Marketing Nel Benessere
General & Plastic Surgery
157d
Cleared
Jun 22, 2021
ICOONE Laser Med (also referred to as ICOONE Medical laser)
I-Tech Industries Srl
General & Plastic Surgery
56d
Cleared
Jan 11, 2019
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
I-Tech Industries Srl
General & Plastic Surgery
126d
About Product Code NUV - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code NUV since 2005, with 19 receiving FDA clearance (average review time: 113 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.