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 K261047
Device Name Dental Diode Laser Device (Laser-Pen)
Applicant
Guilin Kevin Peter Technology Co., Ltd.
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Guilin,  CN 541100
Applicant Contact Libin Zhang
Correspondent
Guilin Kevin Peter Technology Co., Ltd.
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Guilin,  CN 541100
Correspondent Contact Libin Zhang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/31/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-