QPZ · Class II · 21 CFR 878.4340

FDA Product Code QPZ: Contact Cooling For Skin Lesion Pain Relief

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.

Leading manufacturers include R2 Technologies, Inc..

2
Total
2
Cleared
357d
Avg days
2021
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Contact Cooling For Skin Lesion Pain Relief Devices (Product Code QPZ)

2 devices
1–2 of 2
Cleared Nov 10, 2022
Dermal Cooling System
K213294
R2 Technologies, Inc.
General & Plastic Surgery · 405d
Cleared Aug 05, 2021
R2 Dermabrasion Tip (for Dermal Cooling System)
K203006
R2 Technologies, Inc.
General & Plastic Surgery · 308d

About Product Code QPZ - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QPZ since 2021, with 2 receiving FDA clearance (average review time: 357 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QPZ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →