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510(k) Data Aggregation
K Number
K210169Device Name
Hair Growth Device
Manufacturer
Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd
Date Cleared
2021-04-16
(84 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
Device Description
The Hair Growth Device LS-D601 is composed of 26 3R class laser diodes (wavelength: 650-660nm, power<5mW) and 30 red light diodes (wavelength: 640nm-660mm) configured within an outer helmet and protective inner liner.
The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause to therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
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