510(k) Report

Devices descending from P980006

14 later devices reach Pure Vision Visibility Tinted Contact Lens for Extended Wear through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050948Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc.200513—
+2K132715Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensBausch & Lomb, Incorporated20133—
+2K131208Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon…Bausch & Lomb, Inc.20139—
+3K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…INTEROJO, Inc.20260—
+3K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd.20241—
+3K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…Yung Sheng Optical Co., Ltd.20231—
+3K230954Samfilcon B Custom Contact LensBausch + Lomb, Incorporated20230—
+3K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaBausch & Lomb, Incorporated20211—
+3K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated20180—
+3K151918Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue…Bausch & Lomb, Incorporated20160—
+3K143632Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact…Bausch & Lomb, Incorporated20151—
+4K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…HOYA Lamphun, Ltd.20260—
+4K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…Yung Sheng Optical Co., Ltd.20250—
+4K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon…Bausch & Lomb, Incorporated20230—