510(k) K183671
K183671 is an FDA 510(k) premarket notification submitted by Lg Electronics.Inc for the device "LG PRA.L DERMA LED MASK". The FDA issued a decision of Substantially Equivalent on Jan 22, 2019. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810. Lg Electronics.Inc has 32 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 22, 2019
- Date Received
- Dec 27, 2018
- 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
- 510(k)
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.