510(k) K243953

Device: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
Applicant: Vizionfocus, Inc.
510(k) number: K243953
Product code: LPL
Decision: Substantially Equivalent (SESE)
Decision date: 2025-04-10
Date received: 2024-12-23
Regulation: 886.5925
Classification name: Lenses, Soft Contact, Daily Wear
Medical specialty: Ophthalmic
Review panel: Ophthalmic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Angus Shih
Address: # 5, Renyi St., Zhunan Township Miaoli County TW 350 350

FDA Registration Numbers

3005147469
3026035637
2919245
3014054090
3006405660
3004146030
3031092085
3002732585
3006946962
3025414414
1835957
3017889743
3039456814
2918644
3015533540
3003365815
1053053
3009518015
3010640396
3009633067
1066578
9680540
9617710
3010460316
9614154
3008034930
3002807570
3017069344
2032112
3012590738
9710495
3010890435
3014289638
3005395964
3004585750
1065845
3024762292
3043022738
3012719596
1610287
3011771819
3014768085
9610790
3016009612
2024119
3015700153
3012760082
3012918760
1315522
3011521050
1313525
3009104180
3030261726
3033524682
3018616050
1119279
3006297986
3013576528
3008585940
3012138439
3015282628
1052446
3008325767
3004927493
3009076545
1057985
3011649033
3004529384
3010392968
3011861185
3041165456
3036689755
3030421258
3012228452
3007064560
3015146121
2916547
3022375855
3005184723

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LPL

510(k)	Device	Applicant	Decision date
K253352	Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	2026-05-21
K261299	Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	2026-05-19
K253885	PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES	GEO MEDICAL CO., LTD.	2026-04-29
K254269	Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens	St. shine Optical Co., Ltd.	2026-03-19
K252385	Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	2026-03-13
K254052	DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal	Alcon Laboratories, Inc.	2026-02-13
K251683	Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)	Bruno Vision Care, LLC	2025-12-23
K250364	Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens	St. shine Optical Co., Ltd.	2025-10-07
K244009	Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)	Yung Sheng Optical Co., Ltd.	2025-09-25
K251095	Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses	Pegavision Corporation	2025-09-17
K251573	VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens	Vizionfocus, Inc.	2025-09-10
K242855	P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)	E.O.S Co., Ltd.	2025-07-30
K243868	Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	2025-07-02
K242056	miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus	Benq Materials Corporation	2025-04-17
K241884	HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)	Hunan Haipuming Technology Co., Ltd.	2025-03-20