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510(k) Data Aggregation
K Number
K240689Device Name
Robin's Egg
Manufacturer
Telebrands Corporation
Date Cleared
2024-09-17
(188 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Telebrands Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Robin's Egg is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-I to I-4, II-I, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Device Description
The Telebrands' Robin's Egg is a non-invasive, helmet-style photobiomodulation device indicated to treat androgenetic alopecia in both men and women. It is operated using a single button at the front of the helmet to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. The Robin's Egg is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board containing 126 LEDs, as compared to 119 within the predicate device REVIAN RED. The Robin's Egg is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled by means of a single button and illuminated control display at the front of the helmet. Emitting red light energy within the 625 - 660 nm at 2.376 mW/cm² for a treatment time of 10 minutes, the Robin's Egg provides a well-established photobiomodulation effect upon the scalp to stimulate hair growth.
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