SkinPen Precision System
by Crown Aesthetics EUDAMED510(k)
Active
510(k) K202243
Overview
The SkinPen Precision System is a powered microneedle device designed for controlled skin remodelling through microneedling. It delivers precise, adjustable-depth micro-injuries to stimulate collagen production, addressing conditions such as acne scars, fine lines, wrinkles, and uneven texture.
This device is intended for use in clinical settings by trained professionals and is supplied as a reusable system with disposable microneedle cartridges. It operates under FDA 510(k) clearance and EU MDR compliance, with adjustable depth settings up to 2.5 mm for facial and neck treatments. Sterility and single-use cartridge compliance are critical for safe procedural use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK202243 | Date2 Apr 2021 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- QAI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4430
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
SkinPen Precision is the first FDA-cleared microneedling device approved for use on the face and an area of the body. With expanded depth options, SkinPen Precision is safe for use with a depth of up to 2.5 mm on the neck. Procedures take about 30 minutes, depending on the area treated and the desired results.
Other devices from Crown Aesthetics
Questions
What clinical conditions is the SkinPen Precision System intended to address, and how does it work?
The SkinPen Precision System is designed for controlled skin remodelling through microneedling, targeting conditions like acne scars, fine lines, wrinkles, and uneven skin texture. It achieves this by delivering precise, adjustable-depth micro-injuries (up to 2.5 mm) to stimulate collagen production, promoting natural skin renewal.
Is the SkinPen Precision System reusable, and if so, what components are disposable?
Yes, the SkinPen Precision System itself is reusable, but it comes with disposable microneedle cartridges. These cartridges ensure sterility and single-use compliance, which is critical for safe procedural use, as they are intended to be discarded after one use.
What depth settings are available for the SkinPen Precision System, and how does this affect treatment areas?
The SkinPen Precision System offers adjustable depth settings up to 2.5 mm, allowing clinicians to customize treatments for facial and neck areas. This flexibility ensures precise control for addressing various skin concerns while minimizing risk.
How should the SkinPen Precision System be stored, and are there any special handling requirements?
While the device itself is reusable, the disposable microneedle cartridges must be handled with care to maintain sterility. The reusable system should be stored in a clean, dry environment, following manufacturer guidelines to prevent contamination. Cartridges should only be used once and then discarded properly.
What regulatory pathways has the SkinPen Precision System undergone, and what does this mean for clinicians?
The SkinPen Precision System has undergone FDA 510(k) clearance and EU MDR compliance, confirming its safety and effectiveness for controlled skin remodelling. This means clinicians can rely on its regulatory approvals when integrating it into clinical settings for professional use.