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 K231718
Device Name Holmium Medical Laser
Applicant
Allengers Global Healthcare Private Limited
Rm. #5, Khasra # 79, Bhankarpur, Mubarakpur Rd.
Derabassi, District- Mohali,  IN 140507
Applicant Contact Harpreet Singh
Correspondent
Allengers Global Healthcare Private Limited
Rm. #5, Khasra # 79, Bhankarpur, Mubarakpur Rd.
Derabassi, District- Mohali,  IN 140507
Correspondent Contact Harpreet Singh
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/13/2023
Decision Date 08/18/2023
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
-
-