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 Light, Ultraviolet, Dermatological
510(k) Number K262285
Device Name UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)
Applicant
Shijiazhuang Recovery Star Medical Device Co., Ltd.
A8-2-4, Kelin Industrial Park, # 8 Yuanhang Rd., Sijiazhuang
Shijiazhuang,  CN 050200
Applicant Contact Adrian Tse
Correspondent
Shijiazhuang Recovery Star Medical Device Co., Ltd.
A8-2-4, Kelin Industrial Park, # 8 Yuanhang Rd., Sijiazhuang
Shijiazhuang,  CN 050200
Correspondent Contact Adrian Tse
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/06/2026
Decision Date 10/05/2026
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
-
-