510(k) K983021
- Device
- METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC
- Applicant
- METROSOFT, INC.
- 510(k) number
- K983021
- Product code
- LPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-11-13
- Date received
- 1998-08-31
- 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
- No
Applicant Contact#
- Contact
- JIM WEBB
- Address
- 15802 Vision Dr. Pflugerville TX US 78660 78660
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 not indicated by FDA
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 |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. | 2025-04-10 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases