Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4340](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4340) → QPZ — Contact Cooling For Skin Lesion Pain Relief

# QPZ · Contact Cooling For Skin Lesion Pain Relief

_General, Plastic Surgery · 21 CFR 878.4340 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QPZ

## Overview

- **Product Code:** QPZ
- **Device Name:** Contact Cooling For Skin Lesion Pain Relief
- **Regulation:** [21 CFR 878.4340](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4340)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QPZ/K213294.md) | Dermal Cooling System | R2 Technologies, Inc. | Nov 10, 2022 | SESE |
| [K203006](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QPZ/K203006.md) | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | Aug 5, 2021 | SESE |

## Top Applicants

- R2 Technologies, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QPZ](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QPZ)

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