• 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 K202983
Device Name easy Hairfull
Y&J BIO Co., Ltd.
B-916, 947, Hanam-daero
Hanam-si,  KR 12982
Applicant Contact Kwang Sic Kim
MDR Solutions Co., Ltd
1435 Kanjanapisek Road, Bang Khae Nuea
Bangkok,  TH 10160
Correspondent Contact Paweena U-Thainual
Regulation Number890.5500
Classification Product Code
Date Received09/30/2020
Decision Date 12/08/2020
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