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510(k) Data Aggregation
K Number
K243555Device Name
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
Manufacturer
Shenzhen Eyco Technology Co., Ltd
Date Cleared
2025-02-05
(79 days)
Product Code
OLP, OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Eyco Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Mode 1 (Red + Infrared light): treatment of full face wrinkles.
- Mode 2 (Blue light): Treatment of mild to moderate inflammatory acne.
- Mode 3 (Mixed light): Treatment of mild to moderate inflammatory acne.
Device Description
LED phototherapy masks are over-the-counter light-emitting diode (LED) devices that emit energy and are used in dermatology to treat acne and wrinkles. The device emits red (630nm) and infrared (850nm) light to treat wrinkles and blue (415nm) light to treat mild to moderate acne. All models had to be fitted with an eye mask and strapped to the treatment area, and all had a controller to set the parameters of the device. There are 10 models of the device (model: E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A), all of which are operated through a controller.
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