Definition: Skin Resurfacing
| Device Type ID | 5827 |
| Device Name | Skin Resurfacing Rf Applicator |
| Physical State | Hand Held Device With A Range Of Electrodes (64-144) That Penetrate The Top Layer Of The Skin And Then Generates RF Pulses To Create Micro-ablative Points. |
| Technical Method | Applicator Emits RF Energy That Flows Between Electrodes To Create Micro-ablative Points On The Skin, Forming Superficial Ablation With A Volumetric Non Ablative Heating Effect In The Dermis. |
| Target Area | Dermatologic Use |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| 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 Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5827 |
| Device | Skin Resurfacing Rf Applicator |
| Product Code | OUH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ENDYMED MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JEISYS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |