| 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 |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
890.5500
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
