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510(k) Data Aggregation
K Number
K222477Device Name
Hair Growth Device
Manufacturer
Dongguan Lescolton Medical Equipment Co., Ltd
Date Cleared
2022-11-18
(94 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Lescolton Medical Equipment 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 IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. All users should also have Fitzpatrick Skin Types I to IV.
Device Description
The Hair Growth Device LS-D620 is composed of 80 laser diodes (wavelength: 650-660nm, power<5mW) configured within an outer helmet and protective inner liner. The combined light is absorbed by the scalp. The use of diode lasers 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 designed to 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. The Hair Growth Device LS-D620 may produce 20% maximum output deviation in different treatment sites. The device uses a non detachable polymer lithium battery for power supply, and the continuous use time for the battery is 180 minutes. Which meets the requirements of IEC 62133-2 safety standard.
The Hair Growth Device LS-D630 is composed of 162 laser diodes (wavelength: 650-660nm, power<5mW) configured within an outer helmet and protective inner liner. The combined light is absorbed by the scalp. The use of diode lasers 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 designed to 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. The Hair Growth Device LS-D630 may produce 20% maximum output deviation in different treatment sites. The device uses a non detachable polymer lithium battery for power supply, and the continuous use time for the battery is 80 minutes. Which meets the requirements of IEC 62133-2 safety standard.
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