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510(k) Data Aggregation
K Number
K213789Device Name
Intelligence LaserComb
Manufacturer
Date Cleared
2022-06-24
(200 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Yibin Yingtong Intelligent Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Intelligence Laser Comb (Model: YTLC001-W ) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Device Description
The Intelligence Laser Comb (Model: YTLC001-W) is a home-use comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth in men and women. The device provides distributed laser to the scalp at 655+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Comb is an over-the-counter (OTC) device intended for home-use. The Laser Comb works by providing laser energy to stimulate hair follicles. For optimal results, the laser must not be blocked by the hair and must have an unobstructed path to the scalp. The Laser Comb has teeth that part the hair and allow the maximum amount of laser energy to reach the scalp. The Laser Hair Growth Comb design with plastic Mainframe, it is composed of PCB circuit board, Power Button, Indicator Light, Red Laser Light, Teeth, USB charging port. And the device is equipped with one internal rechargeable lithium battery (3.7 V d.c. 500mA) that can be charged directly by external adapter. The device uses beep and vibrate to alert the user to the next step during treatment.
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