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 K231153
Device Name Neuhat Hair Growth System; ibeauty.com Laser Cap
Applicant
Nature Incredible Inc
3422 Old Capitol Trail #569
Wilmington,  DE  19808
Applicant Contact John Lee
Correspondent
Nature Incredible Inc
3422 Old Capitol Trail #569
Wilmington,  DE  19808
Correspondent Contact John Lee
Regulation Number890.5500
Classification Product Code
OAP  
Date Received04/24/2023
Decision Date 06/23/2023
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
-
-