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- Data on file. Related to SkinPen Precision.
- For important safety information, including intended use, contraindications, warnings, precautions, and clinical summaries:
- Patients should consult the Patient Labeling;
- Healthcare professionals should consult the Instructions for Use or User Manual. Clinical data and summaries are derived from regulatory filings, Crown Aesthetics’ clinical studies, internal research, and consumer surveys.
- FDA De Novo Classification: SkinPen Precision System is classified under De Novo DEN160029 as a Class II device, Regulation 878.4430, Product Code QAI, for improving the appearance of facial acne scars.
- FDA 510(k) Clearance: SkinPen Precision System is cleared under 510(k) number K202243 for improving the appearance of wrinkles on the neck.
- Clinical Studies: Select data supporting SkinPen Precision’s efficacy are based on studies conducted by Crown Aesthetics.