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 Lubricant, Personal
510(k) Number K253989
Device Name HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)
Applicant
Maxigen Biotech, Inc.
#88, Keji 1st Rd., Guishan Dist.,
Taoyuan,  TW
Applicant Contact Cheng-Han Chou
Correspondent
Maxigen Biotech, Inc.
#88, Keji 1st Rd., Guishan Dist.,
Taoyuan,  TW
Correspondent Contact Cheng-Han Chou
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/12/2025
Decision Date 09/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-