Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5740](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5740) → OZC — Over The Counter Thermal Treatment For Acne.

# OZC · Over The Counter Thermal Treatment For Acne.

_Physical Medicine · 21 CFR 890.5740 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OZC

## Overview

- **Product Code:** OZC
- **Device Name:** Over The Counter Thermal Treatment For Acne.
- **Regulation:** [21 CFR 890.5740](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5740)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K111341](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OZC/K111341.md) | CLEANE / CLEANE POP | Medicon Co., Ltd. | Feb 29, 2012 | SESE |

## Top Applicants

- Medicon Co., Ltd. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OZC](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OZC)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com