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 K261052
Device Name LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
Applicant
Guangdong Newdermo Biotech Co., Ltd.
Bldg. 70(C28), # 9 Huateng Rd., Jinshan Village, Shiqi Town,
Guangzhou,  CN 511450
Applicant Contact Junyi Xing
Correspondent
Guangdong Newdermo Biotech Co., Ltd.
Bldg. 70(C28), # 9 Huateng Rd., Jinshan Village, Shiqi Town,
Guangzhou,  CN 511450
Correspondent Contact Junyi Xing
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received03/31/2026
Decision Date 06/29/2026
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
-
-