FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MultiCut Solo
K Number: K213597
·
Decision Jan 18, 2023
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
29
Review Days
432
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Basic Information
- Device Name
- MultiCut Solo
- K Number
- K213597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asclepion Laser Technologies GmbH
- Date Received
- November 12, 2021
- Decision Date
- January 18, 2023
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
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Other Clearances by Asclepion Laser Technologies GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K261094 | YellowStar | Apr 29, 2026 | Substantially Equivalent |
| K253100 | MultiPulse TFL | Oct 23, 2025 | Substantially Equivalent |
| K240831 | MultiCut Solo | Nov 6, 2024 | Substantially Equivalent |
| K241600 | Dermablate | Jul 3, 2024 | Substantially Equivalent |
| K240816 | MeDioStar | Apr 23, 2024 | Substantially Equivalent |
| K231876 | MultiPulse HoPLUS | Feb 22, 2024 | Substantially Equivalent |
| K213889 | PicoStar | Apr 22, 2022 | Substantially Equivalent |
| K210634 | MCL 31 Dermablate System | Apr 13, 2022 | Substantially Equivalent |
| K192483 | MeDioStar | Mar 13, 2020 | Substantially Equivalent |
| K161257 | MultiPulse HoPLUS | Mar 31, 2017 | Substantially Equivalent |