510(k) DEN150005
DEN150005 is an FDA 510(k) premarket notification submitted by Endymed Medical, Ltd. for the device "Newa Skin Therapy System". The FDA issued a decision of De Novo Granted on December 18, 2015. The device falls under product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4420. Endymed Medical, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 18, 2015
- Date Received
- January 16, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4420
- Review Panel
- SU
- Submission Type
An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.