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510(k) Data Aggregation
K Number
K232424Device Name
CurrentBody Skin RF
Manufacturer
EL Global Trade Ltd.
Date Cleared
2024-03-06
(208 days)
Product Code
PAY
Regulation Number
878.4420Why did this record match?
Applicant Name (Manufacturer) :
EL Global Trade Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.
Device Description
The CurrentBody Skin RF device is an OTC, home-use hand-held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of: User Interface, Programmable logic controller (PLC, microcontroller) embedded in PCBA, RF power module, Power Supply, RF electrodes. The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.
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K Number
K183260Device Name
Sensilight Pro / Pistol IPL
Manufacturer
EL Global Trade Ltd.
Date Cleared
2019-03-18
(115 days)
Product Code
OHT, ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
EL Global Trade Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6,9 and 12 months after the completion of treatment regimen.
Device Description
The Sensilight Pro is an intense pulse light hair reduction device. Phototherapy (Lightbased) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Sensilight Pro is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Sensilight Pro is 4.5 cm² or 2 cm² (for large and precise treatment windows, respectively).
The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Sensilight Pro is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.
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K Number
K140381Device Name
SENSILIGHT/ SENSILIGHT PLUS
Manufacturer
EL GLOBAL TRADE LTD.
Date Cleared
2014-08-08
(175 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
EL GLOBAL TRADE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Device Description
The sensiLight devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight will not trigger a pulse. (*) The sensiLight Plus model contains in addition, a movement sensor to prevent pulse overlapping.
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K Number
K140527Device Name
SENSILIGHT MINI
Manufacturer
EL GLOBAL TRADE LTD.
Date Cleared
2014-07-31
(149 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
EL GLOBAL TRADE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The sensiLight Mini is an over the counter devices intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Device Description
The sensiLight Mini device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device is 3 cm2. The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.
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