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 K203799
Device Name ProFlex CO2 Laser Fiber
Applicant
InnovaQuartz LLC
23030 N. 15th Ave
Phoenix,  AZ  85027
Applicant Contact Stephen Griffin
Correspondent
InnovaQuartz LLC
23030 N. 15th Ave
Phoenix,  AZ  85027
Correspondent Contact Stephen Griffin
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/28/2020
Decision Date 09/20/2021
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
-
-