| Device |
wound autofluorescence imaging device |
| Regulation Description |
Wound autofluorescence imaging device. |
| Definition |
A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information. |
| Physical State |
The device has a non-contact housing that emits non-coherent excitation light in visible spectrum and captures fluorescence image of the target materials/tissues. No imaging contrast agent are required for autofluorescence imaging. |
| Technical Method |
The imaging device is non-contact medical device and captures autofluorescence images using non-coherent excitation light source in visible spectrum. |
| Target Area |
Wounds through the skin. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QCR |
|---|
| Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
878.4165
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
