FDA 510(k) Applications for Medical Device Product Code "ONE"
(Powered Light Based Non-Laser Surgical Instrument)

FDA 510(k) Number Applicant Device Name Decision Date
K100628 DAAVLIN DISTRIBUTING CO. PLASMALUXLS 11/24/2010
K092800 LED INTELLECTUAL PROPERTIES, LLC ANTI-WRINKLE (AGING) LIGHT, MODEL AAL 02/04/2010
K103415 PHAROS LIFE CORPORATION TANDA MAX 01/03/2011
K171055 Philips Electronics Nederland B.V. Philips BlueControl 07/06/2017
K091467 SILVER BAY, LLC BABY QUASAR 09/17/2010
K091125 VERILUX CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 09/03/2010


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