FDA 510(k)

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

Número K: K251308 · 2026-01-15

Data da decisão2026-01-15

Código do produtoLBI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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