FDA 510(k)

LED Light Therapy Mask (RT01)

Номер K: K242068 · 2025-04-04

ЗаявительNingbo Dechang Electrical Machinery Made Co.,Ltd

Дата решения2025-04-04

Код продуктаOLP

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

LED Light Therapy Mask (RT01) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Dechang Electrical Machinery Made Co.,Ltd. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242068. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the LED Light Therapy Mask (RT01)?

LED Light Therapy Mask (RT01) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Ningbo Dechang Electrical Machinery Made Co.,Ltd. The 510(k) number is K242068.

When did LED Light Therapy Mask (RT01) receive FDA 510(k) clearance?

LED Light Therapy Mask (RT01) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242068.

Who is the listed applicant for LED Light Therapy Mask (RT01)?

The FDA 510(k) record lists Ningbo Dechang Electrical Machinery Made Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Mask (RT01)?

The FDA product code for LED Light Therapy Mask (RT01) is OLP.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OLP)

K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia Corporation K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.

Официальный источник

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