510(k) K142820
- Device
- BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens For Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens For Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens For Daily Wear, BIOLENS To
- Applicant
- ABB Optical Group, LLC
- 510(k) number
- K142820
- Product code
- LPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-30
- Date received
- 2014-09-30
- 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
- John Kenyon
- Address
- 1750 N. Loop Rd., Suite 150 Alameda CA US 94502 94502
FDA Registration Numbers#
- 3010640396
- 1067084
- 3039590526
- 3017069344
- 3009108089
- 3010890435
- 3011649033
- 3024762292
- 3004529384
- 3011080538
- 3003228982
- 1052446
- 3015393207
- 2919245
- 3016009612
- 3003981983
- 3008504746
- 3012760082
- 3010460316
- 3011861185
- 3006514242
- 3013576528
- 3033524682
- 3008034930
- 3013124682
- 9610813
- 9610731
- 3014289638
- 3010392968
- 3013505369
- 9680540
- 9614154
- 3021632375
- 3011553378
- 3003365815
- 3008325767
- 3030262618
- 1066578
- 3012590738
- 3012546757
- 3012918760
- 3017889743
- 3015533540
- 3041165456
- 3030421258
- 3003515967
- 3015332516
- 3008586477
- 3002296055
- 3018616050
- 3015146121
- 2916547
- 1057985
- 3011989923
- 1065845
- 3015282628
- 2032112
- 9617710
- 1053053
- 3022375855
- 1610287
- 3005724763
- 3012138439
- 3009633067
- 3007064560
- 1123818
- 3011521050
- 3009076545
- 3015430860
- 3035385765
- 3012167421
- 2918644
- 3008585940
- 3009518015
- 2640128
- 9614392
- 3026035637
- 3013785060
- 3006946962
Source Documents#
Other 510(k) Records For Product Code LPL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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