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 With Microbeam\Fractional Output
510(k) Number K180036
Device Name SMAXEL CO2 Surgical Laser System
Applicant
Ids, Ltd.
105, Byoksan Digital Valley 3 Cha, Digital-Ro, Guro-Gu
Seoul,  KR 08381
Applicant Contact Kwang Yeong Ahn
Correspondent
Braunsolutions
970 S. Dawson Way Unit 14
Aurora,  CO  80012
Correspondent Contact Alexander Braun Henderson
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received01/05/2018
Decision Date 02/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-