Shedding light on the FDA's 510(k) approvals process: low-level laser therapy devices used in the treatment of androgenetic alopecia

Author:

Wang Sophie1,Seth Divya1,Ezaldein Harib2,Tripathi Raghav1,Merati Miesha2,Muakkassa Fuad2,Scott Jeffrey2

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

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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2. Low-Level Laser Therapy (LLLT) and AGA;Androgenetic Alopecia From A to Z;2023

3. Photobiomodulation in 3D tissue engineering;Journal of Biomedical Optics;2022-09-14

4. Hair transplantation: Basic overview;Journal of the American Academy of Dermatology;2021-10

5. Androgenetic alopecia in transgender and gender diverse populations: A review of therapeutics;Journal of the American Academy of Dermatology;2021-10

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