510(k) K141670
- Device
- ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
- Applicant
- JOHNSON & JOHNSON VISION CARE, INC.
- 510(k) number
- K141670
- Product code
- LPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-09-18
- Date received
- 2014-06-23
- 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
- No
Applicant Contact#
- Contact
- SCOTT DURLAND
- Address
- 7500 Centurion Pkwy., Suite 100 Jacksonville FL US 32256 32256
FDA Registration Numbers#
- 3009633067
- 3035385765
- 3041165456
- 3039456814
- 3036689755
- 3044853379
- 3013170070
- 3009674807
- 3017889743
- 1053053
- 3009518015
- 3012123291
- 3013785060
- 3012862899
- 3043022738
- 1066578
- 3004585750
- 1610287
- 3021632375
- 1119279
- 3004021238
- 3010392968
- 3008034930
- 3012918760
- 1313525
- 1627258
- 3012138439
- 2919245
- 3003228982
- 3006946962
- 3018616050
- 2640128
- 3006297986
- 3003657720
- 2024119
- 3006186389
- 9680540
- 3011989923
- 9614761
- 3013124682
- 3024762292
- 9681121
- 3011521050
- 3011861185
- 3002732585
- 1065845
- 3004146030
- 3033524682
- 1314956
- 9710495
- 3013505369
- 3030262618
- 3011080538
- 3030261726
- 3014289638
- 1052446
- 3026035637
- 3003062331
- 3016009612
- 3003365815
- 3017069344
- 3004529384
- 3006405660
- 3005994941
- 3006015326
- 3022375855
- 3009104180
- 3009108089
- 3012719596
- 9617710
- 3015533540
- 9610790
- 9614154
- 1835957
- 3015332516
- 3012167421
- 3010890435
- 3011771819
- 2032112
Source Documents#
Other 510(k) Records For Product Code LPL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253875 | OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens | Visco Vision, Inc. | 2026-10-23 |
| K262941 | Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens | Bausch + Lomb, Inc. | 2026-10-16 |
| K262495 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | 2026-09-17 |
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | INTEROJO, Inc. | 2026-05-29 |
| 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 |
Legacy Summary#
summary
FDA Review#
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