510(k) K162450
K162450 is an FDA 510(k) premarket notification submitted by Foreo, Inc. for the device "ESPADA Acne-Clearing Blue Light Pen". The FDA issued a decision of Substantially Equivalent on November 30, 2016. The device falls under product code OLP (Over-The-Counter Powered Light Based Laser For Acne), a Class II device regulated under 21 CFR 878.4810. Foreo, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2016
- Date Received
- September 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Powered Light Based Laser For Acne
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
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.