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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: HarmonyXL MultiApplication Platform; Harmony XL Pro; Beauty Rejuve
Classification Name: LASER FOR GASTRO-UROLOGY USE
Product Code: LNK
Device Class: 2
Regulation Number: 878.4810
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: ALMA LASERS LTD.
Registered Establishment Number: 3004167969
Premarket Submission Number: K072564
Owner/Operator: ALMA LASERS LTD.
Owner/Operator Number: 9055441
Establishment Operations: Manufacturer
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