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 Hair Removal
510(k) Number K251176
Device Name IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
Applicant
Shenzhen Mlay Intelligent Technology Co., , Ltd.
201, 301, Bldg. 28, Cuigang Industrial Zone 2, Huaide
Community, Fuyong St., Baoan District, Shenzhen City,
Shenzhen,  CN 518103
Applicant Contact Libin Liu
Correspondent
Shenzhen Mlay Intelligent Technology Co., , Ltd.
201, 301, Bldg. 28, Cuigang Industrial Zone 2, Huaide
Community, Fuyong St., Baoan District, Shenzhen City,
Shenzhen,  CN 518103
Correspondent Contact Libin Liu
Regulation Number878.4810
Classification Product Code
OHT  
Date Received04/16/2025
Decision Date 08/14/2025
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
-
-