DeviceClearance

Product code OZC— Physical Medicine

CLEANE / CLEANE POP

Classification name
Over The Counter Thermal Treatment For Acne.
Device class
Class 2
Regulation
21 CFR 890.5740
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

“For the treatment of mild to moderate inflammatory acne.”

— U.S. Food and Drug Administration, device classification record for product code OZC under 21 CFR 890.5740, via openFDA

Market context for product code OZC

FDA has cleared 1 device under product code OZC, all in 2012, filed by 1 applicant company. 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.

Top applicants under product code OZC

Recent clearances under product code OZC

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