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 K262701
Device Name PicoPeak Picosecond Nd:Yag Laser System (Bella-9)
Applicant
Beijing Sea Heart International Science and Technologyco.Ltd
Rm. 501-2, 5th Floor, Bldg. 4, Yard 7, Xingmao First St., Be
Beijing,  CN 101102
Applicant Contact Kira /
Correspondent
ABMED MEDICAL TECHNOLOGY PTY , Ltd.
48/6 Herbert St.
St Leonards,  AU 2065
Correspondent Contact Boyle Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/31/2026
Decision Date 10/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-