Device |
laser, comb, hair |
Regulation Description |
Infrared lamp. |
Definition |
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v |
Physical State |
Light emitting stimulator |
Technical Method |
Pass laser light emitting comb across the scalp three times a week for at least 26 weeks. |
Target Area |
Growth of scalp hairs |
Regulation Medical Specialty |
Physical Medicine |
Review Panel |
General & Plastic Surgery |
Product Code | OAP |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
890.5500
|
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 |
Not Third Party Eligible |
|
|