510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QPZClass II

Contact Cooling For Skin Lesion Pain Relief

21 CFR 878.4340 / General, Plastic Surgery
FDA source (opens on fda.gov)

QPZ is the FDA product code for Contact Cooling For Skin Lesion Pain Relief, a class II device type, regulated under 21 CFR 878.4340. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QPZ
Device name
Contact Cooling For Skin Lesion Pain Relief
FDA 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.
Regulation
21 CFR 878.4340
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QPZ

By decision year
2 clearances under product code QPZ with a decision year between 2021 and 2022, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QPZ by decision year
YearClearances
20211
20221

Applicants with the most clearances

Product code QPZ
Applicants holding the most 510(k) clearances under product code QPZ
ApplicantClearances
R2 Technologies, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code