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510(k) Data Aggregation
K Number
K233224Device Name
Epilaser Pro
Manufacturer
Epilady 2000 LLC
Date Cleared
2024-01-27
(121 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Epilady 2000 LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Epilaser Pro is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth (defined as a long-term, stable reduction in the number of hairs regrowing) when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Device Description
The Epilaser Pro is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system includes an algorithm that automatically targets individual hairs over the treatment area and the laser activates when it is pressed against the skin. A skin tone sensor ensures the correct skin tone prior to laser activation.
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K Number
K213105Device Name
Epilaser Absolute
Manufacturer
Epilady 2000 LLC
Date Cleared
2022-12-13
(445 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Epilady 2000 LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Epilaser Absolute is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Device Description
The Epilaser Absolute is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system is designed to be manually targeted onto individual hairs and the laser activates when it is pressed against the skin. A skin tone sensor ensures the user has the correct skin tone prior to laser activation.
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K Number
K170970Device Name
Epilaser
Manufacturer
Epilady 2000 LLC
Date Cleared
2017-09-01
(154 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Epilady 2000 LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Device Description
The Epilaser is an over-the-counter, hand-held, hair removal device intended for hair removal on the face below the nose, underarms, and bikini line. It kills the root of the hair follicle using focused laser energy. The system has an integrated microscope and external viewing screen which allows the user to visualize and target individual hairs. The system is composed of a hand held laser containing multiple safety features and a dedicated viewing screen.
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