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 Lenses, Soft Contact, Daily Wear
510(k) Number K240519
Device Name Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
Applicant
Innova Vision, Inc.
2f., # 20, Prosperity Rd. 1, Hsinchu Science Park
Hsinchu,  TW 300091
Applicant Contact Celine Hsu
Correspondent
Andre Vision and Device Research
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Andre Bret
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received02/23/2024
Decision Date 04/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-