• 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 device system, imaging, tympanic membrane and middle ear
510(k) Number K191804
Device Name TOMi Scope
PhotoniCare, Inc.
60 Hazelwood Dr.
champaign,  IL  61820
Applicant Contact ryan shelton
PhotoniCare, Inc.
60 Hazelwood Dr.
champaign,  IL  61820
Correspondent Contact ryan shelton
Regulation Number892.1560
Classification Product Code
Date Received07/05/2019
Decision Date 12/05/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No