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510(k) Data Aggregation
K Number
K222800Device Name
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
Manufacturer
Date Cleared
2022-11-07
(52 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Sanhe Laserconn Tech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Standard-A) is intended for hair removal permanent hair reduction on all 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 Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is solution for fast hair removal with 810nm±10nm high power laser diodes. They are designed with TEC and sapphire cooling unit for skin contact. The laser beam is sublimated with a patented technology of beam shaping for a high efficiency for hair removal solution. This diode laser hair removal can be used for Fitzpatrick skin type I-VI. The pulse energy is up to 40J/cm².
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