SkinPen Precision Elite System— 510(k) K241400
Substantially EquivalentCrown Aesthetics
FDA 510(k) clearance K241400 for SkinPen Precision Elite System, Substantially Equivalent on 2024-08-29. Applicant: Crown Aesthetics. Device class: 2.
Clearance details
- Applicant
- Crown Aesthetics
- Product code
- Code QAI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4430
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
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