FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Fiber Dust
K Number: K210142
·
Decision Mar 11, 2021
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
51
Basic Information
- Device Name
- Fiber Dust
- K Number
- K210142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quanta System Spa
- Date Received
- January 19, 2021
- Decision Date
- March 11, 2021
- 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 Spa
| K Number | Device Name | ||
|---|---|---|---|
| K232236 | Echo | Oct 20, 2023 | Substantially Equivalent |
| K220426 | Fiber Dust PRO | Mar 16, 2022 | Substantially Equivalent |
| K202503 | Chrome | Nov 18, 2020 | Substantially Equivalent |
| K201455 | Litho 150, Cyber Ho 150 | Jun 30, 2020 | Substantially Equivalent |
| K200234 | Surgical laser fibers | Feb 25, 2020 | Substantially Equivalent |
| K181632 | Venacure 1470 Pro | Sep 17, 2018 | Substantially Equivalent |
| K180426 | Empower H35 | Mar 16, 2018 | Substantially Equivalent |
| K163222 | Discovery Pico Family | Dec 5, 2016 | Substantially Equivalent |