FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MeDioStar
K Number: K240816
·
Decision Apr 23, 2024
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
7
Review Days
29
Basic Information
- Device Name
- MeDioStar
- K Number
- K240816
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asclepion Laser Technologies GmbH
- Date Received
- March 25, 2024
- Decision Date
- April 23, 2024
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Asclepion Laser Technologies GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K240831 | MultiCut Solo | Nov 6, 2024 | Substantially Equivalent |
| K241600 | Dermablate | Jul 3, 2024 | Substantially Equivalent |
| K231876 | MultiPulse HoPLUS | Feb 22, 2024 | Substantially Equivalent |
| K213597 | MultiCut Solo | Jan 18, 2023 | Substantially Equivalent |
| K213889 | PicoStar | Apr 22, 2022 | Substantially Equivalent |
| K210634 | MCL 31 Dermablate System | Apr 13, 2022 | Substantially Equivalent |