QDG · Parathyroid Autofluorescence Imaging Device
General, Plastic Surgery · 21 CFR 878.4550 · Class 2
Overview
| Product Code | QDG |
|---|---|
| Device Name | Parathyroid Autofluorescence Imaging Device |
| Regulation | 21 CFR 878.4550 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
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 Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In combination with the general controls of the FD&C Act, the autofluorescence detection device for general surgery and dermatological use is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) Performance testing must demonstrate the sterility of patient-contacting components of the device. (6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin. (8) Labeling must include the following: (i) Instructions for use; (ii) The detection performance characteristics of the device when used as intended; and (iii) A shelf life for any sterile components.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | Nov 28, 2025 | SESE |
| K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Fluoptics Sas (A Getinge Group Company} | Apr 17, 2025 | SESE |
| K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Fluoptics Sas (A Getinge Group Company) | Dec 15, 2023 | SESE |
| K230898 | FLUOBEAM® LX Red | Fluoptics Sas | Jul 28, 2023 | SESE |
| K190891 | Fluobeam LX | Fluoptics | Jul 31, 2019 | SESE |
| DEN170092 | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | Fluoptics | Nov 2, 2018 | DENG |
Top Applicants
- Fluoptics — 2 clearances
- Fluoptics Sas (A Getinge Group Company} — 1 clearance
- Fluoptics Sas (A Getinge Group Company) — 1 clearance
- Fluoptics Sas — 1 clearance
- Dendrite Imaging, Inc. — 1 clearance
