LPL
- 产品代码
- LPL
- 器械名称
- Lenses, Soft Contact, Daily Wear
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 886.5925
- FDA 专业组
- Ophthalmic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 486 件
该代码近三年的 510(k)(36 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260507 | 2026-05-29 | INTEROJO, Inc. | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicon 摘要 |
| K253352 | 2026-05-21 | Pegavision Corporation | Pegavision (Polymacon) Daily Disposable Soft (Hydrop 摘要 |
| K261299 | 2026-05-19 | Pegavision Corporation | Pegavision (Toufilcon B) Daily Disposable Soft (Hydr 摘要 |
| K253885 | 2026-04-29 | GEO MEDICAL CO., LTD. | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (H 摘要 |
| K254269 | 2026-03-19 | St. shine Optical Co., Ltd. | Saview SH Optic 38 UV (Senofilcon A) Visibility Tint 摘要 |
| K252385 | 2026-03-13 | Pegavision Corporation | Pegavision (Toufilcon B) Daily Disposable Soft (Hydr 摘要 |
| K254052 | 2026-02-13 | Alcon Laboratories, Inc. | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal 摘要 |
| K251683 | 2025-12-23 | Bruno Vision Care, LLC | Deseyne (vifilcon C) Daily Disposable Soft (hydrophi 摘要 |
| K250364 | 2025-10-07 | St. shine Optical Co., Ltd. | Saview SH Optic 38 UV (Senofilcon A) Visibility Tint 摘要 |
| K244009 | 2025-09-25 | Yung Sheng Optical Co., Ltd. | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (h 摘要 |
| K251095 | 2025-09-17 | Pegavision Corporation | Pegavision (Hioxifilcon A) Daily Disposable Soft Con 摘要 |
| K251573 | 2025-09-10 | Vizionfocus, Inc. | VizionFocus (somofilcon A) Silicone Hydrogel Soft (h 摘要 |
| K242855 | 2025-07-30 | E.O.S Co., Ltd. | P-CON (polymacon) Soft (hydrophilic) Contact Lenses 摘要 |
| K243868 | 2025-07-02 | Pegavision Corporation | Pegavision (Toufilcon B) Daily Disposable Soft (Hydr 摘要 |
| K242056 | 2025-04-17 | Benq Materials Corporation | miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDEN 摘要 |
| K243953 | 2025-04-10 | Vizionfocus, Inc. | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear C 摘要 |
| K241884 | 2025-03-20 | Hunan Haipuming Technology Co., Ltd. | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Cont 摘要 |
| K242916 | 2025-02-04 | Largan Medical Co., Ltd. | Largan U38 Color (Polymacon) Daily Wear Soft (hydrop 摘要 |
| K243909 | 2025-01-13 | Alcon Laboratories, Inc. | Precision1; Precision1 for Astigmatism; Dailies Tota 摘要 |
| K242413 | 2024-12-17 | Vizionfocus, Inc. | VizionFocus (mififilcon A) Silicone Hydrogel Soft (h 摘要 |
| K232839 | 2024-12-16 | Yung Sheng Optical Co., Ltd. | Eye Secret 38 UV Aspheric (polymacon) and Air Light 摘要 |
| K240918 | 2024-10-25 | Bruno Vision Care, LLC | Deseyne (vifilcon C) Daily Disposable Soft (hydrophi 摘要 |
| K242391 | 2024-10-08 | Lucens Technology Co., Ltd. | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hyd 摘要 |
| K242059 | 2024-08-14 | X-Cel Specialty Contacts, A Walman Opt | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophi 摘要 |
| K241707 | 2024-07-12 | Unicon Optical Co., Ltd. | OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CON 摘要 |
| K240477 | 2024-07-01 | St. shine Optical Co., Ltd. | Saview SH 38 UV (Senofilcon A) Visibility Tinted Sof 摘要 |
| K232649 | 2024-05-08 | Pegavision Corporation | Pegavision (Hioxifilcon A) Daily Disposable Soft Con 摘要 |
| K240519 | 2024-04-17 | Innova Vision, Inc. | Innova Vision (inifilcon A) Silicone Hydrogel (Hydro 摘要 |
| K233221 | 2024-02-06 | Metro Optics of Austin, Inc. | Metro Soft, Silicone Hydrogel Daily Wear Soft Contac 摘要 |
| K234127 | 2024-01-25 | CooperVision, Inc. | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrop 摘要 |
| K223397 | 2024-01-03 | Hoya Lamphun , Ltd. | HOYA Illumina (sorafilcon A) Daily Disposable Soft C 摘要 |
| K233856 | 2023-12-29 | Alcon Laboratories, Inc. | Precision1; Precision1 for Astigmatism; TOTAL30; TOT 摘要 |
| K223585 | 2023-12-20 | Yung Sheng Optical Co., Ltd. | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (h 摘要 |
| K230954 | 2023-11-17 | Bausch + Lomb, Incorporated | Samfilcon B Custom Contact Lens 摘要 |
| K232139 | 2023-11-16 | Innova Vision, Inc. | Innova Vision (inifilcon A) Silicone Hydrogel Soft ( 摘要 |
| K232921 | 2023-11-16 | Alcon Laboratories, Inc. | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTA 摘要 |
FDA 官方分类页: LPL
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。