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 Light Based Over-The-Counter Hair Removal
510(k) Number K261977
Device Name Braun Aura 9 (6042)
Applicant
Cyden Limited
Block A, Bay Studios Business Park,
Fabian Way, Sa1 8qb
Swansea,  GB
Applicant Contact Matthew Silverberg
Correspondent
Cyden Limited
Block A, Bay Studios Business Park,
Fabian Way, Sa1 8qb
Swansea,  GB
Correspondent Contact Matthew Silverberg
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/12/2026
Decision Date 09/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-