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510(k) Data Aggregation
K Number
K173678Device Name
Diode Laser Cap
Manufacturer
Cosmo Far East Technology Limited
Date Cleared
2018-02-28
(90 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Cosmo Far East Technology Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
Device Description
The COSMO-030 and COSMO-010 Diode Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272visible red light-emitting diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack. The COSMO-020 Diode Laser Cap is exactly the same as the COSMO-030 with the exception of the number of diodes which is respective of model (148 diodes in COSMO-020).
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