Definition: A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use.
| Device Type ID | 5905 |
| Device Name | Powered Microneedle Device |
| Physical State | Powered Microneedle Pen With Single Use Needle Cartridge And Multi-use Motorized Base. |
| Technical Method | The Skin Is Mechanically Punctured To The Point Of Pinpoint Bleeding To Create Injuries In The Skin. |
| Target Area | Skin, Face, And Body. |
| Regulation Description | Microneedling Device For Aesthetic Use. |
| 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) |
| CFR Regulation Number | 878.4430 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5905 |
| Device | Powered Microneedle Device |
| Product Code | QAI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Microneedling Device For Aesthetic Use. |
| CFR Regulation Number | 878.4430 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MT.DERM GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |