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510(k) Data Aggregation
K Number
K243330Device Name
LYMA Laser PRO
Manufacturer
LYMA Life Ltd.
Date Cleared
2025-02-21
(120 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LYMA Life Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LYMA Laser PRO is an Over-the-Counter (OTC) light based device intended for the use in treating face wrinkles.
Device Description
The LYMA Laser PRO is a compact, handheld laser device intended to provide low-level laser light therapy (LLLT) for the treatment of wrinkles. The LYMA Laser PRO system is composed of a handheld casing enclosing three low-level, 808nm laser diodes, and three red light-emitting diodes (LED). The device also includes one white LED that inform the user about device status during operation, and optical lenses that diffuse the laser light across a larger treatment window. The LYMA Laser PRO includes a rechargeable battery and is provided with a power cable.
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K Number
K210823Device Name
LYMA Laser
Manufacturer
LYMA Life Ltd.
Date Cleared
2022-03-18
(364 days)
Product Code
OHS, ILY, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LYMA Life Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LYMA Laser is an Over the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
Device Description
The LYMA Laser is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles. The LYMA Laser incorporates a near-infrared LED light source within the optimum Therapeutic Optical Window at 808 nm, optimized for Low Level Light Therapy, and a red LED light source at 620 nm. An optical lens that diffuses the light to produce narrowband, divergent distribution across an 8 cm² treatment area. The energy output of the 808 nm and 620 nm wavelengths is 62.5 mW/cm² which produces a beneficial treatment for full-face wrinkles.
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