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 Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K220729
Device Name The Luminance RED Acne Device
Applicant
Luminance Medical Ventures, Inc.
2310 Henderson Ave.
#1297
Dallas,  TX  75201
Applicant Contact Troy Stites
Correspondent
leanRAQA, LLC
131 E Loch Lomond Dr.
Oro Valley,  AZ  85737
Correspondent Contact Laura Nygard
Regulation Number878.4810
Classification Product Code
OLP  
Date Received03/14/2022
Decision Date 06/09/2022
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
-
-