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510(k) Data Aggregation
K Number
K202631Device Name
iHelmet Laser Comb
Manufacturer
Slinph Technologies Co., Ltd
Date Cleared
2020-12-08
(88 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Slinph Technologies Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iHelmet Laser Comb is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ha-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Device Description
The iHelmet Laser Comb is a comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth. The device provides distributed laser to the scalp at 650+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Hair Therapy is designed as handheld product, and it consists of main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the treatment is completed.
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K Number
K190467Device Name
iHelmet Hair Growth System
Manufacturer
Slinph Technologies Co., LTD
Date Cleared
2019-12-26
(303 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Slinph Technologies Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Device Description
iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.
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K Number
K162782Device Name
iHelmet Hair Growth System
Manufacturer
Slinph Technologies Co., LTD
Date Cleared
2017-04-04
(183 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Slinph Technologies Co., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.
Device Description
iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.
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