Contact Cooling For Skin Lesion Pain Relief

QPZ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4340

Classification

FDA Product Code: QPZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4340
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown