Device |
suntan bed |
Regulation Description |
Sunlamp products and ultraviolet lamps intended for use in sunlamp products. |
Definition |
A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | REF |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4635
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review
|
Accredited Persons
|