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510(k) Data Aggregation
K Number
K181878Device Name
Kiierr 272 Laser, Kiierr 148 Laser
Manufacturer
Kiierr International, LLC
Date Cleared
2018-09-05
(54 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Kiierr International, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kiierr Family of Devices, the 272 and 148 Laser Devices are 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 of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.
Device Description
The Kiierr Family of Devices, the 272 and 148 Lasers each contain the listed number of diodes 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 Kiierr Family of Devices, the 272 and 148 Lasers are powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical.
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