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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 a medical device manufactured by Thera B Medical Products. It received FDA 510(k) clearance on 2026-01-15 under approval 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. It is manufactured by Thera B Medical Products. The 510(k) number is K251308.

When was SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) approved by the FDA?

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

What company makes SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)?

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) is manufactured by Thera B Medical Products.

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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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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