Device class
Class II
Regulation 878.4590
Total clearances
14
2021-11-15 → 2026-05-21
Definition
What is Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4590
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 |
| 17999 |
CPT
|
— |
Low
|
Focused ultrasound aesthetic use; may be unlisted or non-covered OTC procedure |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-05-21 |
K260618 |
Ulthera, Inc.
|
Ulthera® System |
| 2025-05-13 |
K250418 |
Ulthera, Inc.
|
Ulthera System (UC-1 Control Unit PRIME Model 2.1) |
| 2025-02-24 |
K243035 |
Ulthera, Inc.
|
Ulthera® System |
| 2024-05-30 |
K240687 |
Sofwave Medical, Ltd.
|
SofWave System |
| 2024-02-22 |
K233996 |
Ulthera, Inc.
|
Ulthera System (UC-1 Control Unit PRIME) |
| 2023-12-22 |
K233104 |
Sofwave Medical, Ltd.
|
SofWave System |
| 2023-12-14 |
K232455 |
Sofwave Medical, Ltd.
|
SofWave System |
| 2023-11-03 |
K230100 |
Classys, Inc.
|
SCIZER (SC1-M410) |
| 2023-09-29 |
K231628 |
Beshape Technologies , Ltd.
|
BeShape One Device |
| 2023-08-28 |
K231537 |
Sofwave Medical, Ltd.
|
SofWave System |
| 2023-04-18 |
K230820 |
Sofwave Medical, Ltd.
|
SofWave System |
| 2023-03-14 |
K230019 |
Sofwave Medical, Ltd.
|
SofWave System |
| 2022-12-16 |
K223237 |
Sofwave Medical, Ltd.
|
SofWave System |
| 2021-11-15 |
K211483 |
Sofwave Medical, Ltd.
|
SofWave System |