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510(k) Data Aggregation
K Number
K192569Device Name
Diode Laser Therapy System
Manufacturer
Date Cleared
2019-12-13
(86 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
San He Lefis Electronics Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Diode Laser Therapy System is intended for 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
The proposed device, Diode Laser, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
Function module description
a. Power System
b. Microprocessor Control System
c. Operation Display System
d. Cooling System
e. Handpiece module
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