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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: C-WAVE LED MASK FOR NECK & DECOLLETE; decoLITE; decoLITE RIO; Dermapenworld Neck and Decollete; Omnilux Contour Neck and Decollete; UnveiLED Neck & Decollete
Classification Name: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
Product Code: OHS
Device Class: 2
Regulation Number: 878.4810
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: I-SMART Development LTD.
Registered Establishment Number: 3013481783
Premarket Submission Number: K242382
Owner/Operator: I-smart marketing/development LTD.
Owner/Operator Number: 10061409
Establishment Operations: Specification Developer
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