FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
F65 Laser System
K Number: K222790
·
Decision Jun 14, 2023
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
6
Review Days
272
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Basic Information
- Device Name
- F65 Laser System
- K Number
- K222790
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumenis Be, Ltd.
- Date Received
- September 15, 2022
- Decision Date
- June 14, 2023
- Product Code
- OAP
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| OAP | Laser, Comb, Hair | FDA class 2 | Physical Medicine |
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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 |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | Dec 1, 2023 | Substantially Equivalent |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories | May 18, 2022 | Substantially Equivalent |