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510(k) Data Aggregation
K Number
K240611Device Name
IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
Manufacturer
Date Cleared
2024-06-20
(107 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Ivylaser (Beijing) Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode(FHR).
Device Description
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece, which intended for temporary hair reduction in Fast Hair Removal Mode(FHR). It consists of a main unit, a foot switch and a handle-piece. The foot switch and the handle switch are activated to start emitting light pulses. The hand-piece has a cooled light outlet. The laser parameters and other system functions are controlled by a control panel on the main unit.
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K Number
K230025Device Name
IVYLASER Handhold Hair Removal Machine
Manufacturer
Date Cleared
2023-07-03
(180 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Ivylaser (Beijing) Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent har reduction 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 is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. It is also intended for permanent hair reduction
Three models (iyoung mini-P, iyoung mini-GY, iyoung mini-GN) are included in IVYLASER Handhold Hair Removal Machine series products, and they have the same intended purposes and working theories.
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