510(k) K221430
K221430 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 July 27, 2022. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), 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
- July 27, 2022
- Date Received
- May 17, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over The Counter Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.