Device |
light based imaging |
Regulation Description |
Surgical lamp. |
Definition |
Emission and collection of light to create an image for medical purposes |
Physical State |
Device is a light source in a housing and light detectors in a housing that can be aimed at a target tissue |
Technical Method |
Device emits light that is collected from the target tissue and then analyzed to provide information about the target |
Target Area |
Intact human skin |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | PSN |
Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4580
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|