Last synced on 2 December 2022 at 11:04 pm

Wound Autofluorescence Imaging Device

Page Type
Product Code
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 and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4165
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4165 Wound autofluorescence imaging device

§ 878.4165 Wound autofluorescence imaging device.

(a) Identification. 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.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

[83 FR 52968, Oct. 19, 2018]

Wound Autofluorescence Imaging Device

Page Type
Product Code
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 and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4165
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4165 Wound autofluorescence imaging device

§ 878.4165 Wound autofluorescence imaging device.

(a) Identification. 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.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

[83 FR 52968, Oct. 19, 2018]