BC-001+ Acne Purifier
FDA 510(k) K170260 · Oriental Inspiration Limited
510(k) numberK170260
Submission
- Device name
- BC-001+ Acne Purifier
- Applicant
- Oriental Inspiration Limited
Hong Kong, CN - Received
- January 27, 2017
- Decision date
- April 25, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLP – Over-The-Counter Powered Light Based Laser For Acne
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
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Questions and answers
When was BC-001+ Acne Purifier cleared by the FDA?
BC-001+ Acne Purifier (K170260) received a 510(k) decision of Substantially Equivalent on April 25, 2017, 88 days after the submission was received.
What is the product code of K170260?
The FDA product code is OLP – Over-The-Counter Powered Light Based Laser For Acne, a Class II (moderate risk) device regulated under 21 CFR 878.4810.