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 Booth, Sun Tan
510(k) Number K180576
Device Name Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
Applicant
Lpi, Inc.
506 Twin Oaks Dr.
Johnson City,  TN  37601
Applicant Contact Christopher Steadman
Correspondent
Lpi, Inc.
506 Twin Oaks Dr.
Johnson City,  TN  37601
Correspondent Contact Christopher Steadman
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received03/05/2018
Decision Date 04/19/2018
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
-
-