510(k) Report

Devices descending from K020927

26 later devices reach Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132854Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd.20136—
+1K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation20132—
+1K082883Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily WearI-See Vision Technology, Inc.20091—
+1K050948Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc.200513—
+2K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd.20220—
+2K151847SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact LensSmart Performer Corp., Ltd.20160—
+2K143190Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensYung Sheng Optical Co., Ltd.20150—
+2K143052Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd.20143—
+2K132714Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and…Vision Science Co., Ltd.20141—
+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—
+3K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear…Yung Sheng Optical Co., Ltd.20152—
+3K143632Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact…Bausch & Lomb, Incorporated20151—
+3K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl20140—
+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—
+4K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd.20241—
+4K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon…Bausch & Lomb, Incorporated20230—
+5K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20260—