510(k) K180447
K180447 is an FDA 510(k) premarket notification submitted by Led Technologies, Inc. for the device "reVive Light Therapy LED Cleansing System". The FDA issued a decision of Substantially Equivalent on June 4, 2018. 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. Led Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2018
- Date Received
- February 20, 2018
- 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.