510(k) Report

Devices descending from K950294

3 later devices reach Flexlens 55 Soft (Hydrophilic) Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030593Flexlens and Harrison Post Refractive Surgery (Bioxifilcon a), (Hioxifilcon B)…X-Cel Contacts, A Walman Co.20030—
+1K023077Ocu-Flex Pediatric Aphakic (Ocufilcon B) Spherical Soft Contact Lens for Daily Wear…Ocu-Ease Optical Products, Inc.20020—
+1K962000Flexlens (Methafilcon a)Flexlens, Inc.19960—