- 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.
– SkinPen® Precision Elite Instructions for Use (SPP Elite IFU), P31A
– SkinPen® Precision System De Novo Summary (DEN160029), p21A
– Bellus Medical – SkinPen® Precision (Validation Dossier), Full Document
– SkinPen® Precision Elite Instructions for Use (SPP Elite IFU), P19A
– 2021 Wamsley MN FLAW (2021 FLAW), P11A
– SkinPen® Precision Elite Instructions for Use (SPP Elite IFU), P25A / P32A
– SkinPen® Precision Elite Instructions for Use (SPP Elite IFU), P32A
– SkinPen® Precision Elite Instructions for Use (SPP Elite IFU), p35A
– SkinPen® Precision Elite Instructions for Use (SPP Elite IFU), p25A
– SkinPen® Precision Elite Instructions for Use (SPP Elite IFU), p30A