Definition: Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.
| Device Type ID | 5800 |
| Device Name | Light Based Over-the-counter Hair Removal |
| Physical State | Use Of Thermal Energy |
| Technical Method | Use Of Thermal Energy To Kill Hair Follicles For Hair Removal |
| Target Area | The Device Generally Targets Skin (including Dermis, Epidermis), Underlying Soft Tissue And Hair Follicles. |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 878.4810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OHT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5800 |
| Device | Light Based Over-the-counter Hair Removal |
| Product Code | OHT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| CFR Regulation Number | 878.4810 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CONAIR CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CYDEN LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
EL GLOBAL TRADE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
HOME SKINOVATIONS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SHEN ZHEN COSBEAUTY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN GSD TECH CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELLQUEST INTL., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1 |