Product code LPL
- Device name
- Lenses, Soft Contact, Daily Wear
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.5925
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N17676S028 | BAUSCH AND LOMB HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES | Bausch & Lomb, Inc. | 2002-06-28 |
| P940013S007 | PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR | Alcon Laboratories, Inc. | 2001-10-04 |
| N17752S038 | HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS | Ciba Vision Corporation | 2001-08-16 |
| N17752S037 | SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A) | Ciba Vision Corporation | 2000-09-18 |
| N17987S026 | CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS | Ciba Vision Corporation | 1999-08-30 |
| P850077S022 | SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN | CooperVision, Inc. | 1997-03-10 |
| P940013S005 | PRECISION(TM) UV (VASURFILCON) | Alcon Laboratories, Inc. | 1996-10-07 |
| P850079S028 | HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES | CooperVision, Inc. | 1996-08-01 |
| P860040S013 | BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES | Wavetouch Technologies, LLC | 1995-11-27 |
| N17752S036 | HYDROCURVE (BUFILCON A CONTACT LENSES) | Ciba Vision Corporation | 1995-09-22 |
| P850077S021 | SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN | CooperVision, Inc. | 1995-05-25 |
| P850079S026 | HYDRASOFT KERATOCONUS METHAFILCON B | CooperVision, Inc. | 1995-05-15 |
| P850077S018 | REVOLUTIONS (TM) ALT. MANU. SITE CONTACTS | CooperVision, Inc. | 1995-05-05 |
| P850077S019 | SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN | CooperVision, Inc. | 1995-04-28 |
| P940013S004 | PRECISION(TM) UV (VASURFILCON) | Alcon Laboratories, Inc. | 1995-04-19 |
| N18033S027 | VISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS | Vistakon, Johnson & Johnson Vision Products, Inc. | 1995-02-13 |
| P940013S001 | PRECISION(TM) UV (VASURFILCON) | Alcon Laboratories, Inc. | 1995-02-09 |
| P860040S011 | SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES | Wavetouch Technologies, LLC | 1994-12-12 |
| P940013S002 | PRECISION(TM) UV (VASURFILCON) | Alcon Laboratories, Inc. | 1994-11-09 |
| N17752S035 | HYDROCURVE | Ciba Vision Corporation | 1994-11-09 |
| P890049S003 | FINISHED METHAFILCON A CONTACT LENSES | Lombart Lenses, Ltd. | 1994-07-06 |
| P850079S025 | HYDRASOFT KERATOCONUS METHAFILCON B | CooperVision, Inc. | 1994-06-24 |
| P880101S006 | AQUAFLEX DAILY & EXTENDED WEAR HYDROPHILIC LENS | Unilens Corporation, USA | 1994-06-13 |
| P830006S007 | SOFTACT II (POLYMACON) | Premier Contact Lens | 1994-03-01 |
| P860040S012 | SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES | Wavetouch Technologies, LLC | 1994-01-27 |
| P910029S002 | \YDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES | Les Laboratories Blonchard | 1993-11-23 |
| P820086S011 | CIBATINT(TM) TINTING PROCESS | Ciba Vision Care | 1993-11-23 |
| P820059S020 | POLYMACON CONTACT LENSES | Wesley Jessen Corp. | 1993-11-23 |
| P780007S039 | POLYMACON CONTACT LENSES | CooperVision, Inc. | 1993-11-23 |
| P850002S009 | SIMULVUE (HEFILCON A) BIFOCAL CONTACT LENS | Unilens Corp., USA | 1993-11-17 |
Related 510(k) Records#
| 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) ... | 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) Visibil... | 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) Visibil... | 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 |
| K241884 | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Hunan Haipuming Technology Co., Ltd. | 2025-03-20 |
| K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2025-02-04 |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Alcon Laboratories, Inc. | 2025-01-13 |
| K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | Vizionfocus, Inc. | 2024-12-17 |
| K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. | 2024-12-16 |
| K240918 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism | Bruno Vision Care, LLC | 2024-10-25 |
| K242391 | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Lucens Technology Co., Ltd. | 2024-10-08 |
| K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | X-Cel Specialty Contacts, A Walman Optical Company | 2024-08-14 |
| K241707 | OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ | Unicon Optical Co., Ltd. | 2024-07-12 |
| K240477 | Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (H... | St. shine Optical Co., Ltd. | 2024-07-01 |
| K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | 2024-05-08 |
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | Innova Vision, Inc. | 2024-04-17 |
| K233221 | Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Metro Optics of Austin, Inc. | 2024-02-06 |
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | CooperVision, Inc. | 2024-01-25 |
| K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | Hoya Lamphun , Ltd. | 2024-01-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00847835000184 | Flexlens | X-Cel Specialty Contacts | 2026-02-25 |
| 08800071419518 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-18 |
| 08800071419594 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419587 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419570 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419563 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419549 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419532 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419525 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419501 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419495 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419488 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419471 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419464 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419457 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419440 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419433 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419426 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419419 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419402 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419396 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419389 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419372 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419365 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419358 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419341 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419334 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419327 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071419310 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |
| 08800071415435 | Another Me Kristin Monthly | DK MEDIVISION Co.,Ltd. | 2026-02-11 |