Product code QPZ

Device name

Contact Cooling For Skin Lesion Pain Relief

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4340

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset