OZC · Over The Counter Thermal Treatment For Acne.
Physical Medicine · 21 CFR 890.5740 · Class 2
Overview
| Product Code | OZC |
|---|---|
| Device Name | Over The Counter Thermal Treatment For Acne. |
| Regulation | 21 CFR 890.5740 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
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 | CLEANE / CLEANE POP | Medicon Co., Ltd. | Feb 29, 2012 | SESE |
Top Applicants
- Medicon Co., Ltd. — 1 clearance
