Identifiers
- 510(k) Number
- DEN160029 FDA 510(k)
- FDA Product Code
- QAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4430 FDA 510(k)
- Regulation Number
- 878.4430 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The SkinPen Precision System is a powered microneedle device used for microneedling procedures. It is designed to create controlled micro-injuries in the skin to stimulate collagen production and improve skin texture and appearance.
The device is supplied by Bellus Medical, LLC and is FDA 510(k) cleared. It is a Class II medical device with product code QAI. The system is intended for use in general and plastic surgery settings, though specific indications are not provided in the device data.
Frequently asked questions
What is the SkinPen Precision System used for?
The SkinPen Precision System is a powered microneedle device designed for microneedling procedures. It creates controlled micro-injuries in the skin to stimulate collagen production and improve skin texture and appearance.
How is the SkinPen Precision System supplied?
The SkinPen Precision System is supplied by Bellus Medical, LLC. It is a Class II medical device with product code QAI, intended for use in general and plastic surgery settings.
What is the regulatory status of the SkinPen Precision System?
The SkinPen Precision System is FDA 510(k) cleared with decision code DENG and K-number DEN160029. It received FDA clearance on March 1, 2018, and is classified under product code QAI.
What settings is the SkinPen Precision System intended for?
The SkinPen Precision System is intended for use in general and plastic surgery settings. While it creates controlled micro-injuries to stimulate collagen production, specific indications are not provided in the device data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Products | Bellus Medical - Crown Aesthetics, About Us | Bellus Medical - Crown Aesthetics, Meet Bellus Medical - info.skinpen.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN160029 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bellus Medical, Llc
Sources (1)
- FDA 510(k) DEN160029 24 fields · synced Sep 24, 2026