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510(k) Data Aggregation
K Number
K244048Device Name
Medi Lift Mask
Manufacturer
YA-MAN Ltd
Date Cleared
2025-01-16
(16 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
YA-MAN Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Device Description
The Medi Lift Mask is composed of a mask made of silicone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device is not operated during charging.
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K Number
K220198Device Name
Medi Lift PLUS
Manufacturer
YA-MAN Ltd
Date Cleared
2023-06-28
(520 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
YA-MAN Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Device Description
The Medi Lift PLUS is composed of a mask made of silcone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device. The device is not operated during charging.
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K Number
K112016Device Name
L-SER KO LAMP
Manufacturer
YA-MAN LTD
Date Cleared
2012-02-10
(211 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
YA-MAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The L-SER-KO IR Lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Device Description
The L-SER-KO IR Lamp is intended for use as an infrared heat lamp. The L-SER-KO IR Lamp is a non-invasive device that emits light energy to the skin surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature. The L-SER-KO IR Lamp delivers an invisible laser beam in the infrared spectrum at wavelengths of 810 nm using a gallium aluminum arsenide (GaAlAs) source. The laser beam is generated by an IR diode. The tissue to be treated is illuminated by non-therapeutic red LED guide lights. The L-SER-KO IR Lamp consists of only one hardware component, a handpiece containing the controller, user interface display and the treatment aperture. The handpiece is made of standard medical PVC material.
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K Number
K032944Device Name
YA-MAN LASER 21
Manufacturer
YA-MAN LTD
Date Cleared
2003-12-19
(88 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
YA-MAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ya-Man, Ltd. Laser 21 diode laser system is indicated for the removal of unwanted hair in Fitzpatrick skin types I-IV.
Device Description
Not Found
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K Number
K011021Device Name
LASER 20
Manufacturer
YA-MAN LTD
Date Cleared
2001-10-09
(188 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
YA-MAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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