Device class
Class II
Regulation 878.4550
Total clearances
6
2021-06-22 → 2026-02-24
Definition
What is Autofluorescence Imaging Adjunct Tool For Wounds
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4550
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
MolecuLight, Inc.
|
3 |
0 |
2022-05-18 |
|
Precision Healing, LLC |
1 |
0 |
2023-12-05 |
|
Kent Imaging, Inc.
|
1 |
0 |
2025-03-26 |
|
Swift Medical, Inc. |
1 |
1 |
2026-02-24 |
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 |
| 97607 |
CPT
|
— |
Medium
|
Negative pressure wound therapy; adjunct imaging tool used with wound care |
| 99070 |
CPT
|
— |
Medium
|
Supplies and materials; autofluorescence imaging device as adjunct tool |
| 15002 |
CPT
|
— |
Low
|
Surgical debridement; if device used to guide wound assessment and treatment |
Pulse
Most recent 510(k) clearances