FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elite iQ PRO (M122K1)
K Number: K240396
·
Decision Mar 8, 2024
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
8
Review Days
29
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Basic Information
- Device Name
- Elite iQ PRO (M122K1)
- K Number
- K240396
- 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
- Cynosure, LLC
- Date Received
- February 8, 2024
- Decision Date
- March 8, 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 Cynosure, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K261570 | PICOSURE WORKSTATION | Jun 17, 2026 | Substantially Equivalent |
| K230510 | MyEllevate | Jul 6, 2023 | Substantially Equivalent |
| K223292 | TempSure System | Nov 23, 2022 | Substantially Equivalent |
| K212891 | TempSure System | Mar 18, 2022 | Substantially Equivalent |
| K210226 | PicoSure Workstation | Mar 30, 2021 | Substantially Equivalent |
| K200241 | TempSure System | Mar 25, 2020 | Substantially Equivalent |
| K193426 | Elite iQ | Mar 9, 2020 | Substantially Equivalent |