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 K160549
Device Name MEDICAL DIODE LASER SYSTEMS
Applicant
Wuhan Gigaa Optronics Technology Co., Ltd.
5, 6/F, Unit A, B, Bldg. B8, Hi-Tech Medical Device
Industrial Park, #818 Gaoxin Ave.
East Lake Development Zone, Wuhan,  CN 430206
Applicant Contact NIE XINXING
Correspondent
Wuhan Gigaa Optronics Technology Co., Ltd.
5, 6/F, Unit A, B, Bldg. B8, Hi-Tech Medical Device
Industrial Park, #818 Gaoxin Ave.
East Lake Development Zone, Wuhan,  CN 430206
Correspondent Contact NIE XINXING
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/29/2016
Decision Date 04/07/2017
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
-
-