Device class
Class II
Regulation 878.4420
Total clearances
9
2021-02-25 → 2026-01-06
Definition
What is Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
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.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4420
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| G0285 |
HCPCS
|
— |
Medium
|
Skin treatment/cosmetic procedure; over-the-counter aesthetic RF device likely subject to non-coverage or patient-pay |
Pulse
Most recent 510(k) clearances