510(k) K111341
K111341 is an FDA 510(k) premarket notification submitted by Medicon Co., Ltd. for the device "CLEANE / CLEANE POP". The FDA issued a decision of Substantially Equivalent on February 29, 2012. The device falls under product code OZC (Over The Counter Thermal Treatment For Acne.), a Class II device regulated under 21 CFR 890.5740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 29, 2012
- Date Received
- May 12, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over The Counter Thermal Treatment For Acne.
- Device Class
- Class II
- Regulation Number
- 890.5740
- Review Panel
- SU
- Submission Type
For the treatment of mild to moderate inflammatory acne.