Device class
Class II
Regulation 878.4550
Total clearances
4
2023-07-28 → 2025-11-28
Definition
What is Parathyroid Autofluorescence Imaging Device
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 |
|
Dendrite Imaging, Inc. |
1 |
1 |
2025-11-28 |
|
Fluoptics Sas (A Getinge Group Company} |
1 |
0 |
2025-04-17 |
|
Fluoptics Sas |
1 |
0 |
2023-07-28 |
|
Fluoptics Sas (A Getinge Group Company) |
1 |
0 |
2023-12-15 |
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 |
| 38562 |
CPT
|
— |
Medium
|
Parathyroid imaging/intraoperative identification; autofluorescence detection aid |
| 60240 |
CPT
|
— |
Medium
|
Parathyroidectomy; adjunct imaging device for surgical guidance |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-11-28 |
K253303 |
Dendrite Imaging, Inc.
|
Dendrite Imaging System |
| 2025-04-17 |
K250455 |
Fluoptics Sas (A Getinge Group Company}
|
FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) |
| 2023-12-15 |
K233564 |
Fluoptics Sas (A Getinge Group Company)
|
FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) |
| 2023-07-28 |
K230898 |
Fluoptics Sas
|
FLUOBEAM® LX Red |