FDA product code QPZ: Contact Cooling For Skin Lesion Pain Relief
QPZ is the FDA product code for contact cooling for skin lesion pain relief. It is a Class II device, regulated under 21 CFR 878.4340 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under QPZ, 1 in the last five years. The average 510(k) review took 356 days (median 356).
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.
Classification
| Field | Value |
|---|---|
| Device name | Contact Cooling For Skin Lesion Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 878.4340 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QPZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 308 |
| 2022 | 1 | 405 |
Compare with all 510(k) review times · Search every QPZ clearance
Top QPZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R2 Technologies, Inc. | 2 | 2022-11-10 |
Most recent QPZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213294 | R2 Technologies, Inc. | Dermal Cooling System | 2022-11-10 | 405 |
| K203006 | R2 Technologies, Inc. | R2 Dermabrasion Tip (for Dermal Cooling System) | 2021-08-05 | 308 |
Recalls for QPZ devices
openFDA lists no recalls for product code QPZ.
Frequently asked questions
What is FDA product code QPZ?
QPZ is the FDA product code for contact cooling for skin lesion pain relief. It is a Class II device, regulated under 21 CFR 878.4340 and reviewed by the General and Plastic Surgery panel.
What device class is QPZ?
Class II, regulation 21 CFR 878.4340. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPZ?
Across 2 cleared submissions the average was 356 days from receipt to decision (median 356).
Which companies have the most QPZ clearances?
R2 Technologies, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QPZ
- Run a recall and safety report across every QPZ manufacturer
- Watch product code QPZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times