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 Laser, Comb, Hair
510(k) Number K261253
Device Name Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)
Applicant
Ziree Co., Ltd.
Rm. 606, Floor 6th, Unit 1, Bldg. 6, Chaoshi Intelligent Ind
Changsha,  CN 410114
Applicant Contact Aijie Peng
Correspondent
Huaxiajiamei (Beijing) Information Consulting Co.,Ltd
B2 Floor, Zhongguancun Dongsheng Science And Technology Park
# 66 Xixiaolu Rd., Haidian District
Beijing,  CN 100192
Correspondent Contact Linda Li
Regulation Number890.5500
Classification Product Code
OAP  
Date Received04/16/2026
Decision Date 06/26/2026
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
Predetermined Change
Control Plan Authorized		 No
-
-