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 K213225
Device Name Diode Laser System GP900A8, Diode Laser System GP900Q8
Applicant
Shenzhen Gsd Tech Co., Ltd.
Bldg. A, Junsd Hi-Tech Park, W. Of Bao’An Rd.
Watch & Clock Base, Guangming District
Shenzhen,  CN 518106
Applicant Contact Huifang Yao
Correspondent
Shenzhen Gsd Tech Co., Ltd.
Bldg. A, Junsd Hi-Tech Park, W. Of Bao’An Rd.
Watch & Clock Base, Guangming District
Shenzhen,  CN 518106
Correspondent Contact Huifang Yao
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/29/2021
Decision Date 12/22/2021
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
-
-