Device class
Class II
Regulation 878.4340
Total clearances
3
2020-01-21 → 2024-09-12
Definition
What is Dermal Cooling Pack/Vacuum/Massager
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4340
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Zeltiq Aesthetics, Inc.
|
2 |
0 |
2021-11-05 |
|
Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics |
1 |
0 |
2024-09-12 |
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 |
| 96999 |
CPT
|
— |
Medium
|
Unlisted special dermatologic procedure for aesthetic body contouring |
| 97999 |
CPT
|
— |
Medium
|
Unlisted physical medicine/rehabilitation service or procedure |
Pulse
Most recent 510(k) clearances