Device Type ID | 5702 |
Device Name | Epilator, High Frequency, Needle-type |
Regulation Description | Needle-type Epilator. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 878.5350 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KCW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5702 |
Device | Epilator, High Frequency, Needle-type |
Product Code | KCW |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Needle-type Epilator. |
CFR Regulation Number | 878.5350 [🔎] |