DeviceClearance

Product code QPZ— General, Plastic Surgery

Dermal Cooling System

Classification name
Contact Cooling For Skin Lesion Pain Relief
Device class
Class 2
Regulation
21 CFR 878.4340
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.”

— U.S. Food and Drug Administration, device classification record for product code QPZ under 21 CFR 878.4340, via openFDA

Market context for product code QPZ

FDA has cleared 2 devices under product code QPZ between 2021 and 2022, 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.

Clearances per year

Top applicants under product code QPZ

Recent clearances under product code QPZ

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