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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: vShape Ultra; Accent Prime
Classification Name: ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
Product Code: IMI
Device Class: 2
Regulation Number: 890.5300
Medical Specialty: Physical Medicine
Registered Establishment Name: ALMA LASERS LTD.
Registered Establishment Number: 3004167969
Premarket Submission Number: K160075
Owner/Operator: ALMA LASERS LTD.
Owner/Operator Number: 9055441
Establishment Operations: Manufacturer
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