FDA 510(k), K100116, LASERTOUCHONE (OTC)
FDA 510(k), K100116, LASERTOUCHONE (OTC)
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510(K) Number: K100116
Device Name: LASERTOUCHONE (OTC)
Manufacturer: LASER HEALTH TECHNOLOGIES, LLC
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 01/15/2010
Decision Date: 04/15/2010
Regulation Medical Specialty: Neurology
Device Name: LASERTOUCHONE (OTC)
Manufacturer: LASER HEALTH TECHNOLOGIES, LLC
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 01/15/2010
Decision Date: 04/15/2010
Regulation Medical Specialty: Neurology