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510(k) Data Aggregation
K Number
K250830Device Name
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
Manufacturer
Shenzhen Sungrow LED Technology Co., Ltd.
Date Cleared
2025-06-09
(82 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Sungrow LED Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Red light: Treatment of full-face wrinkles.
- Yellow light: Treatment of full-face wrinkles.
- Red+Infrared light: Treatment of full-face wrinkles.
- Blue light: Treatment of mild to moderate inflammatory acne.
- Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.
Device Description
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