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 K193367
Device Name elysion-pro
Applicant
High Technology Products SLU
Pasaje Masoliver 24
Barcelona,  ES 08005
Applicant Contact Sergi Lozano
Correspondent
Freyr Global Regulatory Solutions and Services
Level 4 Building No. H-08, Phoenix SEZ Phase 2
Gachibowli, Hyderabad,  IN 500081
Correspondent Contact Vardhini Kirthivas
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/04/2019
Decision Date 03/12/2020
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
-
-