• 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 K240064
Device Name Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
Applicant
Won Tech Co., Ltd.
64 Techno8-ro, Yuseong-gu
Daejeon,  KR 34028
Applicant Contact Yoon HyunSik
Correspondent
Won Tech Co., Ltd.
64 Techno8-ro, Yuseong-gu
Daejeon,  KR 34028
Correspondent Contact Yoon HyunSik
Regulation Number890.5500
Classification Product Code
OAP  
Date Received01/09/2024
Decision Date 02/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-