Product code IMB— Physical Medicine

DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM

Classification name
Cabinet, Moist Steam
Device class
Class 2
Regulation
21 CFR 890.5250
Advisory panel
Physical Medicine
Total cleared
5
First cleared
Most recent

Market context for product code IMB

FDA has cleared 5 devices under product code IMB between 1977 and 2002, filed by 5 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 IMB

Recent clearances under product code IMB

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