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Found 21 results
510(k) Data Aggregation
K Number
K243362Device Name
SmoothSkin Pure Switch (SSC1)
Manufacturer
CyDen Limited
Date Cleared
2024-11-27
(29 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch is also indicated for the permanent reduction in hair regrowth, 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 SSC1 device is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
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K Number
K240587Device Name
SmoothSkin Pure Unplugged (SSB3)
Manufacturer
CyDen Limited
Date Cleared
2024-03-29
(28 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmoothSkin Pure Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged is also indicated for the permanent reduction in hair regrowth, 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 SmoothSkin Pure Unplugged is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is battery powered and charged by mains. The handset with removal battery pack, Handset Dock station, and AC Adapter. AC mains is fed to the AC Adapter and converted to DC to charge the battery pack via the docking station contact pins, the device cannot be used when charging. The battery pack is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
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K Number
K233782Device Name
SmoothSkin Pure Adapt (SSG3)
Manufacturer
CyDen Limited
Date Cleared
2023-12-20
(23 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt is also indicated for the permanent reduction in hair regrowth, 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 SmoothSkin Pure Adapt is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use.
The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp.
Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair sharty is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
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K Number
K230911Device Name
Braun Skin i.expert
Manufacturer
CyDen Limited
Date Cleared
2023-04-27
(27 days)
Product Code
OHT, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Braun Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert is also indicated for the permanent reduction in hair regrowth, 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
Not Found
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K Number
K213692Device Name
SmoothSkin Pure Mini
Manufacturer
CyDen Limited
Date Cleared
2022-01-26
(64 days)
Product Code
OHT, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure Mini is also indicated for the permanent reduction in hair regrowth, 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
Not Found
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K Number
K211994Device Name
Braun Silk.expert Mini
Manufacturer
CyDen Limited
Date Cleared
2021-07-28
(30 days)
Product Code
OHT, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BRAUN Silk.expert Mini Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Mini is also indicated for the permanent reduction in hair regrowth, 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
Not Found
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K Number
K200184Device Name
SmoothSkin Pure
Manufacturer
CyDen Limited
Date Cleared
2020-02-21
(28 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure is also indicated for the permanent reduction in hair regrowth, defined as the longterm, 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
Not Found
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K Number
K192010Device Name
SmoothSkin BARE+
Manufacturer
CyDen Limited
Date Cleared
2019-09-24
(57 days)
Product Code
OHT, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmoothSkin BARE+ Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin BARE+ is also indicated for the permanent reduction in hair regrowth, 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
Not Found
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K Number
K190354Device Name
BRAUN Silk.expert Pro 5
Manufacturer
CyDen Limited
Date Cleared
2019-03-18
(31 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BRAUN Silk.expert Pro 5 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 5 is also indicated for the permanent reduction in hair regrowth, 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
Not Found
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K Number
K190366Device Name
BRAUN Silk Expert Pro 3
Manufacturer
CyDen Limited
Date Cleared
2019-03-18
(31 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CyDen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BRAUN Silk.expert Pro 3 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 3 is also indicated for the permanent reduction in hair regrowth, 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
Not Found
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