Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K251308
Device Name SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
Applicant
Thera B Medical Products
325 E. Grand River Ave. Suite 332
East Lansing,  MI  48823
Applicant Contact Alexa Jones
Correspondent
Acorn N Oakes, LLC
333 N. Dobson Rd. Suite 5
Chandler,  AZ  85224
Correspondent Contact Amy Oakes
Regulation Number880.5700
Classification Product Code
LBI  
Date Received04/28/2025
Decision Date 01/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-