510(k) K182774
K182774 is an FDA 510(k) premarket notification submitted by Pollogen, Ltd. for the device "STOP U (Packed Black USA), STOP U (Packed White USA)". The FDA issued a decision of Substantially Equivalent on June 19, 2019. 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. Pollogen, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2019
- Date Received
- October 1, 2018
- Clearance Type
- Traditional
- 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.