• 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 K180617
Device Name Hair Up
Applicant
Y&J BIO Co, Ltd.,
No. C-413, Munjeong Hyundai Knowledge Center 1,
7, Beobwon-gil
Seoul,  KR 05836
Applicant Contact Kwang Sic Kim
Correspondent
BT Solutions, Inc.
91-14 Seolleung-ri #402
Gangnam-gu,  KR 06150
Correspondent Contact Mina Joo
Regulation Number890.5500
Classification Product Code
OAP  
Date Received03/08/2018
Decision Date 06/01/2018
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
-
-