510(k) K230013

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 30, 2023

Date Received

January 3, 2023

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.