Home / Companies / Guangdong Newdermo Biotech Co., Ltd.
5 FDA records filed under this company name, from 2023 to 2026, in microcurrent and ems (NFO, 1), light for wrinkles (OHS, 4).
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510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The LED Light Therapy Mask (Model: LED Face Mask Pro FAC08NA)is an Over-the-Counter (OTC) device. 1.Red light(630 nm): Intended for treatment of wrinkles. 2.Amber light (605 nm) : Intended for treatment of wrinkles. 3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of …”
“The LED Light Therapy Mask (Model: LED Face Mask Pro FAC08NA)is an Over-the-Counter (OTC) device. 1.Red light(630 nm): Intended for treatment of wrinkles. 2.Amber light (605 nm) : Intended for treatment of wrinkles. 3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles. 4. Blue light(415 nm): Intended for treatment of mild to moderate inflammatory acne. 5. Blue and Red (415 nm and 630 nm): Intended for treatment of mild to moderate inflammatory acne. 6. Near-Infrared(830 nm): The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The LED Light Therapy Mask (Model: LED Chest Mask Pro FAC09NA)is an Over-the-Counter (OTC) device. 1.Red light(630 nm): Intended for treatment of wrinkles. 2.Amber light (605 nm) : Intended for treatment of wrinkles. 3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles. 4. Near-Infrared(830 nm): The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The LED Light Therapy Mask adopts the latest LED light therapy technology, combining 6 kinds of Model: K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K. The LED Light Therapy Mask (Model:K9C-TK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to …”
“The LED Light Therapy Mask adopts the latest LED light therapy technology, combining 6 kinds of Model: K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K. The LED Light Therapy Mask (Model:K9C-TK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Amber light(605nm): Intended for treatment of wrinkles. 4. Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 5.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne. The LED Light Therapy Mask (Models:K9C-K, K9P-YK, K9P-K) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 4.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne. The LED Light Therapy Mask(Model: FM-03BK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles. 1.Red light (630nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. The LED Light Therapy Mask (Model: FM-09K) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Red light (630nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 4.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The LED Light Therapy Mask is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.