• 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 laser, comb, hair
510(k) Number K171775
Device Name Theradome LH80 PRO
Applicant
Theradome Inc.
4900 Hopyard Rd, Ste 100
Pleasanton,  CA  94588
Applicant Contact Tamim Hamid
Correspondent
Theradome Inc.
4900 Hopyard Rd, Ste 100
Pleasanton,  CA  94588
Correspondent Contact Tamim Hamid
Regulation Number890.5500
Classification Product Code
OAP  
Date Received06/14/2017
Decision Date 01/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-