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 Laser Surgical Instrument
510(k) Number K123293
Device Name PASTELLE Q-SWITCHED ND: YAG LASER
Applicant
Won Technology Co., Ltd.
24125 85th Ave. SE
Woodinville,  WA  98072
Applicant Contact Roberta Hines
Correspondent
Won Technology Co., Ltd.
24125 85th Ave. SE
Woodinville,  WA  98072
Correspondent Contact Roberta Hines
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/22/2012
Decision Date 04/11/2013
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
Predetermined Change
Control Plan Authorized		 No
-
-