DeviceClearance

Product code PBX— General, Plastic Surgery

TRUSCULPT

Classification name
Massager, Vacuum, Radio Frequency Induced Heat
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
79
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code PBX under 21 CFR 878.4400, via openFDA

Market context for product code PBX

FDA has cleared 79 devices under product code PBX between 2012 and 2026, filed by 44 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 PBX

Recent clearances under product code PBX

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