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
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
2
Review Days
90
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 |
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Other Clearances by Lumenis Be, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K222790 | F65 Laser System | Jun 14, 2023 | Substantially Equivalent |