Device class
Class II
Regulation 878.4405
Total clearances
3
2023-10-06 → 2024-10-30
Definition
What is Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4405
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 |
| 0071T |
CPT
|
— |
High
|
Focused ultrasound ablation of tissue; Category III code for emerging focused ultrasound procedure |
| 76999 |
CPT
|
— |
Medium
|
Unlisted ultrasound procedure; fallback if specific focused ultrasound code unavailable |
Pulse
Most recent 510(k) clearances