SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)— 510(k) K251308

Name: FDA 510(k) clearance K251308
Creator: U.S. Food and Drug Administration
Published: 2026-01-15

Substantially Equivalent

Thera B Medical Products

FDA 510(k) clearance K251308 for SnugLit(TM) Wearable Phototherapy System (SNGL-01-US), Substantially Equivalent on 2026-01-15. Applicant: Thera B Medical Products. Device class: 2.

Clearance details

Applicant: Thera B Medical Products
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2025-04-28
Decision date: 2026-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Lansing, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.