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 K150578
Device Name Capillus 272 Office Pro
Applicant
Capillus, LLC
1430 South Dixie Highway, Suite 304
Coral Gables,  FL  33146
Applicant Contact Patricia Schnoor
Correspondent
Capillus, LLC
1430 South Dixie Highway, Suite 304
Coral Gables,  FL  33146
Correspondent Contact Patricia Schnoor
Regulation Number890.5500
Classification Product Code
OAP  
Date Received03/09/2015
Decision Date 06/09/2015
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
-
-