510(k) K020917
- Device
- SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
- Applicant
- St. shine Optical Co., Ltd.
- 510(k) number
- K020917
- Product code
- LPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-06
- Date received
- 2002-03-21
- 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
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kevin Walls
- Address
- 13 Red Fox Ln. Littleton CO US 80127 80127
FDA Registration Numbers#
- 3015533540
- 3012546757
- 3011861185
- 1315522
- 3006015326
- 3013576528
- 3010460316
- 3011649033
- 3005395964
- 3013124682
- 1066578
- 3008325767
- 9681121
- 3009104180
- 3012590738
- 2640128
- 3005184723
- 3011771819
- 1119279
- 3030421258
- 9610731
- 1123818
- 1057985
- 3035385765
- 3006297986
- 3011080538
- 3012167421
- 3013170070
- 3004927493
- 1313525
- 1835957
- 3004146030
- 3003657720
- 3014289638
- 3006514242
- 3025414414
- 3012719596
- 3006186389
- 9614761
- 3004585750
- 3009674807
- 3012918760
- 3026035637
- 1053053
- 3002807570
- 3010890435
- 3008034930
- 3006946962
- 3010392968
- 3009076545
- 9710495
- 1627258
- 3003981983
- 3035373204
- 3005724763
- 3004021238
- 3015430860
- 9617499
- 9610813
- 3011521050
- 3008504746
- 3012228452
- 3005147469
- 3024762292
- 8040277
- 3043022738
- 1052446
- 3008586477
- 9617710
- 3012760082
- 1610287
- 3007064560
- 3015282628
- 3002296055
- 3009108089
- 3011989923
- 3017069344
- 3014768085
- 9680540
Source Documents#
510(k) summary PDF not indicated by FDA
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 |