FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO Pen Microneedling System (6883)
K Number: K243800
·
Decision Aug 25, 2025
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
25
Applicant Total
1
Review Days
257
Basic Information
- Device Name
- PRO Pen Microneedling System (6883)
- K Number
- K243800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4430
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dermalogica, LLC
- Date Received
- December 11, 2024
- Decision Date
- August 25, 2025
- Product Code
- QAI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QAI | Powered Microneedle Device | FDA class 2 | General, Plastic Surgery |
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