Cleane / Cleane Pop
FDA 510(k) K111341 · Medicon Co., Ltd.
510(k) numberK111341
Submission
- Device name
- Cleane / Cleane Pop
- Applicant
- Medicon Co., Ltd.
Fullerton, CA, US - Received
- May 12, 2011
- Decision date
- February 29, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZC – Over The Counter Thermal Treatment For Acne.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5740
- Specialty
- Physical Medicine
For the treatment of mild to moderate inflammatory acne.
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Questions and answers
When was Cleane / Cleane Pop cleared by the FDA?
Cleane / Cleane Pop (K111341) received a 510(k) decision of Substantially Equivalent on February 29, 2012, 293 days after the submission was received.
What is the product code of K111341?
The FDA product code is OZC – Over The Counter Thermal Treatment For Acne., a Class II (moderate risk) device regulated under 21 CFR 890.5740.