FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
K Number: K223404
·
Decision Jan 20, 2023
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
2
Review Days
72
Basic Information
- Device Name
- Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
- K Number
- K223404
- 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
- Quanta System, S.p.A.
- Date Received
- November 9, 2022
- Decision Date
- January 20, 2023
- 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 Quanta System, S.p.A.
| K Number | Device Name | ||
|---|---|---|---|
| K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Sep 17, 2019 | Substantially Equivalent |