Contact Cooling For Skin Lesion Pain Relief
The Contact Cooling Device for Skin Lesion Pain Relief is a surgical device used in dermatological procedures for the removal of benign skin lesions, as well as for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures through the application of controlled cooling. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 878.4340 in the General and Plastic Surgery specialty. It carries product code QPZ and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QPZ
- Device Class
- FDA class 2
- Regulation Number
- 878.4340
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.