FDA Product Code PBX: Massager, Vacuum, Radio Frequency Induced Heat
Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.
Leading manufacturers include Zimmer Medizinsysteme GmbH, Bios S.R.L. and Weero Co., Ltd..
FDA 510(k) Cleared Massager, Vacuum, Radio Frequency Induced Heat Devices (Product Code PBX)
About Product Code PBX - Regulatory Context
510(k) Submission Activity
78 total 510(k) submissions under product code PBX since 2012, with 78 receiving FDA clearance (average review time: 183 days).
Submission volume has remained relatively stable over the observed period, with 16 submissions in the last 24 months.
FDA Review Time
FDA review times for PBX submissions have been consistent, averaging 182 days recently vs 184 days historically.
PBX devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →