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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: truSculpt; truSculpt iD
Classification Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product Code: GEI
Device Class: 2
Regulation Number: 878.4400
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Johari Digital Healthcare Ltd.
Registered Establishment Number: 8040537
Premarket Submission Number: K180709
Owner/Operator: Johari Digital Healthcare Ltd.
Owner/Operator Number: 10023876
Establishment Operations: Contract Manufacturer
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