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510(k) Data Aggregation
K Number
K211192Device Name
Grivamax Family of Lasers, Models 272 and 148
Manufacturer
Date Cleared
2021-07-20
(90 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Leana Orders, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Grivamax Family of Lasers , Models 272 and 148 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Device Description
The Grivamax Family of Lasers, Models 272 and 148 consist of 272 diode lasers or 148 diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The Grivamax Family of Lasers, Models 272 and 148 are powered by a lithium-ion battery pack that contains an embedded controller chip.
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K Number
K171895Device Name
Grivamax Hair Growth System
Manufacturer
Date Cleared
2017-08-22
(57 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Leana Orders, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Grivamax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Device Description
The Grivamax Hair Growth System consists of 272 diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The Grivamax Hair Growth System is powered by a lithium-ion battery pack that contains an embedded controller chip.
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