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FDA 510(k), K062991, GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
FDA 510(k), K062991, GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
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510(K) Number: K062991
Device Name: GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
Manufacturer: LIGHT BIOSCIENCE, LLC
Device Classification Name: light based over the counter wrinkle reduction
Regulation Number: 878.4810
Classification Product Code: OHS
Date Received: 09/29/2006
Decision Date: 02/15/2008
Regulation Medical Specialty: General & Plastic Surgery
Device Name: GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
Manufacturer: LIGHT BIOSCIENCE, LLC
Device Classification Name: light based over the counter wrinkle reduction
Regulation Number: 878.4810
Classification Product Code: OHS
Date Received: 09/29/2006
Decision Date: 02/15/2008
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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