F65 Laser System— 510(k) K222790
Substantially EquivalentLumenis Be, Ltd.
FDA 510(k) clearance K222790 for F65 Laser System, Substantially Equivalent on 2023-06-14. Applicant: Lumenis Be, Ltd.. Device class: 2.
Clearance details
- Applicant
- Lumenis Be, Ltd.
- Product code
- Code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yokneam, IL
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