FDA 510(k)

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

Номер K: K251308 · 2026-01-15

Дата решения2026-01-15

Код продуктаLBI

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) is the device name listed in this FDA 510(k) record. The listed applicant is Thera B Medical Products. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K251308. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)?

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Thera B Medical Products. The 510(k) number is K251308.

When did SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) receive FDA 510(k) clearance?

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) received FDA 510(k) clearance on 2026-01-15, under 510(k) number K251308.

Who is the listed applicant for SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)?

The FDA 510(k) record lists Thera B Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)?

The FDA product code for SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) is LBI.

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: LBI)

K243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited K190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated K172656BiliLuxDraeger Medical Systems, Inc.

Официальный источник

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