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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Auralux; DiamondLux; UltraClear Infinity
Classification Name: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT
Product Code: ONG
Device Class: 2
Regulation Number: 878.4810
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Acclaro Corporation
Registered Establishment Number: 3021550489
Premarket Submission Number: K233803
Owner/Operator: Acclaro Corporation
Owner/Operator Number: 10084236
Establishment Operations: Manufacturer
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