F65 Laser System— 510(k) K222790

Substantially Equivalent

Lumenis Be, Ltd.

FDA 510(k) clearance K222790 for F65 Laser System, Substantially Equivalent on 2023-06-14. Applicant: Lumenis Be, Ltd..

Clearance details

Applicant: Lumenis Be, Ltd.
Product code: Code OAP
Advisory panel: Physical Medicine
Date received: 2022-09-15
Decision date: 2023-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

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