OZC — Over The Counter Thermal Treatment For Acne. Class II
FDA product code OZC covers "Over The Counter Thermal Treatment For Acne.", a Class II medical device regulated under 21 CFR 890.5740. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OZC
- Device Class
- Class II
- Regulation Number
- 890.5740
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
For the treatment of mild to moderate inflammatory acne.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K111341 | medicon co | CLEANE / CLEANE POP | February 29, 2012 |