Definition: Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V
| Device Type ID | 5481 |
| Device Name | Laser, Comb, Hair |
| 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 Description | Infrared Lamp. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.5500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5481 |
| Device | Laser, Comb, Hair |
| Product Code | OAP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infrared Lamp. |
| CFR Regulation Number | 890.5500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APIRA SCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CAPILLUS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
COSMO FAR EAST TECHNOLOGY LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LEXINGTON INTERNATIONAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NUTRA LUXE MD, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PULSADERM LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SLINPH TECHNOLOGIES CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUPER GROW LASERS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
THERADOME INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THERADOME, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TROPHY SKIN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operational Issue | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 2 |