• 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 K160728
Device Name NutraStim Hair Laser Helmet
Applicant
NUTRA LUXE MD LLC
12801 COMMONWEALTH DR. UNIT 2-6
FORT MYERS,  FL  33976
Applicant Contact GLORIA AVENDANO
Correspondent
NUTRA LUXE MD LLC
12801 COMMONWEALTH DR. UNIT 2-6
FORT MYERS,  FL  33976
Correspondent Contact GLORIA AVENDANO
Regulation Number890.5500
Classification Product Code
OAP  
Date Received03/16/2016
Decision Date 09/16/2016
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
-
-