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 K242908
Device Name UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
Applicant
Shanghai Sigma High-Tech Co., Ltd.
The W. Wing, 1st Floor., Bldg. #7&The E. Wing, 11th Floor
Bldg. #8, #388 Shuanglian Rd., Xujing Town, Qingpu D
Shanghai,  CN
Applicant Contact Xing Guo
Correspondent
Microkn Medical Technology Service (Shanghai) Co., Ltd.
Rm. 901, Huafa Center, 889 Pinglu Rd.
Jing'An District, Shanghai
Shanghai,  CN 200040
Correspondent Contact He Owen
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/24/2024
Decision Date 12/19/2024
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
-
-