FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
K Number: K220467
·
Decision May 18, 2022
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
6
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
- K Number
- K220467
- 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
- Lumenis Be, Ltd.
- Date Received
- February 17, 2022
- Decision Date
- May 18, 2022
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Lumenis Be, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253803 | MILAN System | Jun 2, 2026 | Substantially Equivalent |
| K250809 | Stellar M22 | Apr 16, 2025 | Substantially Equivalent |
| K242349 | FoLix | Sep 9, 2024 | Substantially Equivalent |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | Dec 1, 2023 | Substantially Equivalent |
| K222790 | F65 Laser System | Jun 14, 2023 | Substantially Equivalent |