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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Smoothskin Gold
Classification Name: LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL
Product Code: OHT
Device Class: 2
Regulation Number: 878.4810
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: CYDEN LIMITED
Registered Establishment Number: 3004635398
Premarket Submission Number: K162231
Owner/Operator: CYDEN LIMITED
Owner/Operator Number: 9060768
Establishment Operations: Specification Developer; Complaint File Establishment
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