510(k) Report

Devices descending from K131208

9 later devices reach Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…INTEROJO, Inc.20260—
+1K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd.20241—
+1K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…Yung Sheng Optical Co., Ltd.20231—
+1K230954Samfilcon B Custom Contact LensBausch + Lomb, Incorporated20230—
+1K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated20180—
+1K143632Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact…Bausch & Lomb, Incorporated20151—
+2K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…HOYA Lamphun, Ltd.20260—
+2K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…Yung Sheng Optical Co., Ltd.20250—
+2K151918Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue…Bausch & Lomb, Incorporated20160—