Shedding light on the FDA's 510(k) approvals process: low-level laser therapy devices used in the treatment of androgenetic alopecia
Author:
Affiliation:
1. Case Western Reserve University School of Medicine, Cleveland, OH, USA;
2. Department of Dermatology, University Hospitals Cleveland Medical Center, Cleveland, OH, USA
Publisher
Informa UK Limited
Subject
Dermatology
Link
https://www.tandfonline.com/doi/pdf/10.1080/09546634.2018.1528327
Reference5 articles.
1. Androgenetic alopecia: An update
2. Efficacy of non-surgical treatments for androgenetic alopecia: a systematic review and network meta-analysis
3. Center for Devices and Radiological Health. Premarket Notification 510(k). U S Food and Drug Administration Home Page. 2018; [cited 2018 Jul 12]. Available from: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
4. Classifications of patterned hair loss: a review
5. Illuminating current pitfalls in optimal photobiomodulation device development and assessment for treating hair loss
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