FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Exceed Unlimited
K Number: K233709
·
Decision Feb 23, 2024
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
20
Applicant Total
1
Review Days
95
Basic Information
- Device Name
- Exceed Unlimited
- K Number
- K233709
- 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
- Mt.Derm GmbH
- Date Received
- November 20, 2023
- Decision Date
- February 23, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QAI), ordered by most recent decision date.
E-PEN (E-PEN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1NEED Pro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XCELLARISPRO TWIST microneedling device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SER Pen Carain MicroSystem (MP1209SP)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SkinPen Precision Elite System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dr. pen Microneedling System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery