FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
K Number: K233301
·
Decision Dec 1, 2023
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
6
Review Days
63
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Basic Information
- Device Name
- ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
- K Number
- K233301
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lumenis Be, Ltd.
- Date Received
- September 29, 2023
- Decision Date
- December 1, 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 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 |
| K222790 | F65 Laser System | Jun 14, 2023 | Substantially Equivalent |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories | May 18, 2022 | Substantially Equivalent |