QPZ · Contact Cooling For Skin Lesion Pain Relief
General, Plastic Surgery · 21 CFR 878.4340 · Class 2
Overview
| Product Code | QPZ |
|---|---|
| Device Name | Contact Cooling For Skin Lesion Pain Relief |
| Regulation | 21 CFR 878.4340 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.
Classification Rationale
Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213294 | Dermal Cooling System | R2 Technologies, Inc. | Nov 10, 2022 | SESE |
| K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | Aug 5, 2021 | SESE |
Top Applicants
- R2 Technologies, Inc. — 2 clearances
