510(k) Report

Devices descending from K230824

2 later devices reach IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—
+1K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Metro Optics of Austin, Inc.20240—