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 powered light based non-laser surgical instrument with thermal effect
510(k) Number K120080
Device Name SHASER HRS2 HAIR REMOVAL SYSTEM
Applicant
SHASER, INC.
32 HARRISON ST.
MELROSE,  MA  02176
Applicant Contact GLEN EMELOCK
Correspondent
SHASER, INC.
32 HARRISON ST.
MELROSE,  MA  02176
Correspondent Contact GLEN EMELOCK
Regulation Number878.4810
Classification Product Code
ONF  
Date Received01/11/2012
Decision Date 05/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-