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 Based Over The Counter Wrinkle Reduction
510(k) Number K253054
Device Name LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
Applicant
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
3rd Floor, Bldg. A, # 281 Huating Rd.
Shuiwei Community, Dalang St., Longhua District
Shenzhen,  CN 518110
Applicant Contact Tianfei He
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received09/22/2025
Decision Date 12/19/2025
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
-
-