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 K262183
Device Name Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
Applicant
Shenzhen Nuon Medical Equipment Co., Ltd.
1f-3f, #27-2, Xintang Rd., Xintian Comm, Fuhai St., Baoan Di
Shenzhen,  CN 518000
Applicant Contact Alain Dijkstra
Correspondent
Shenzhen Nuon Medical Equipment Co., Ltd.
1f-3f, #27-2, Xintang Rd., Xintian Comm, Fuhai St., Baoan Di
Shenzhen,  CN 518000
Correspondent Contact Anna He
Regulation Number890.5500
Classification Product Code
OAP  
Date Received06/29/2026
Decision Date 09/24/2026
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
-
-