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FDA 510(k)

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

K-Number: K251308 · 2026-01-15

ApplicantThera B Medical Products
Decision Date2026-01-15
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: LBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical IncorporatedK172656BiliLuxDraeger Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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