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510(k) Data Aggregation
K Number
K220381Device Name
Diode Laser Therapy Systems
Manufacturer
Beijing LaserTell Medical Co., Ltd.
Date Cleared
2022-05-20
(99 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing LaserTell Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diode Laser Therapy Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
Diode Laser Therapy Systems is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); The Diode Laser Therapy Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch. The Diode Laser Therapy Systems utilize the principle of photoepilation for hair removal. The Photoepilation is a technique for removal of unwanted hair by thermal destruction of the hair follicle and its reproductive system (stems cells). The heat is caused by selective absorption of electromagnetic radiation emitted by laser light sources. As melanin is the main chromophore existing in hair follicles, so the melanin could absorb the energy from the laser, which would result in temperature rapid increase, then the hair follicle and its reproductive system (stems cells) would be destroyed by increased high temperature without damage epidermis and the surrounding normal tissue.
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