510(k) Report

Devices descending from K120756

2 later devices reach LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142820BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS…Abb Optical Group, LLC20150—
+1K133079IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2 Toric…Alden Optical Labs., Inc.20131—