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 K252427
Device Name Diode Laser Hair Removal Machine (GLD01)
Applicant
Sanhe Meditech Co., Ltd.
#15 Bldg, Zhongnan High-Tech Industrial Park, Liushan St.
Yanjiao
Sanhe,  CN 065201
Applicant Contact Xiaoxia Song
Correspondent
Sanhe Meditech Co., Ltd.
#15 Bldg, Zhongnan High-Tech Industrial Park, Liushan St.
Yanjiao
Sanhe,  CN 065201
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/01/2025
Decision Date 10/31/2025
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
-
-