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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: GEX Applicant: Gyrus ACMI, Inc. Decision Date To: 06/07/2024
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soltive pro superpulsed laser, soltive premium superpulsed laser, soltive superpulsed laser fibers, and accessories Gyrus ACMI, Inc. K221306 01/27/2023
soltive laser system (soltive pro superpulsed laser, soltive premium superpulsed laser, soltive laser fibers, and accessories) Gyrus ACMI, Inc. K211401 06/03/2021
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