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 Laser For Disruption Of Adipocyte Cells For Aesthetic Use
510(k) Number K231131
Device Name Diode Laser Body Sculpture Systems
Applicant
Shanghai Bele Medical Technology Co.,Ltd
Rm. 402, 4f, Bldg. 1, #3255 Shengang Rd.,
Songjiang District
Shanghai,  CN 201600
Applicant Contact Jeremy Li
Correspondent
Shanghai Bele Medical Technology Co.,Ltd
Rm. 402, 4f, Bldg. 1, #3255 Shengang Rd.,
Songjiang District
Shanghai,  CN 201600
Correspondent Contact Jeremy Li
Regulation Number878.5400
Classification Product Code
PKT  
Date Received04/21/2023
Decision Date 06/22/2023
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
-
-