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510(k) Data Aggregation
K Number
K173843Device Name
illumiflow 148 Laser Cap
Manufacturer
EGlobal, LLC
Date Cleared
2018-01-26
(39 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
EGlobal, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The illumiflow 148 Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila to V or females with androgenic alopecia who have Ludwig-Savin Hair Classifications of I-II and both with Fitzpatrick Skin Phototypes I to IV
Device Description
Similar to the original illumiflow 272 Laser Cap and the predicate LaserCap 120, the modified illumiflow 148 Laser Cap is a low-level laser therapy (LLLT) helmet device containing red. visible light diode lasers operating at 650 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.
The illumiflow 148 Laser Cap utilizes 148 laser diodes to deliver laser stimulation to the scalp. The device is operated via a single button on the battery pack, and has an audible timer that automatically turns the lasers off after a 30-minute treatment session.
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K Number
K162071Device Name
IllumiFlow Laser Cap
Manufacturer
EGLOBAL, LLC
Date Cleared
2017-02-24
(212 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
EGLOBAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The illumiflow Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV.
Device Description
The illumiflow 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 272 visible red light-emitting diodes at 650-nm and 5mW each. The cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included Battery Pack.
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