One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
FDA 510(k) K180819 · Menicon Co, Ltd.
510(k) numberK180819
Submission
- Device name
- One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
- Applicant
- Menicon Co, Ltd.
Nagoya, JP - Received
- March 29, 2018
- Decision date
- May 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPL – Lenses, Soft Contact, Daily Wear
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5925
- Specialty
- Ophthalmic
Other 510(k)s with product code LPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…LPL · Traditional | INTEROJO, Inc. | 05/29/2026SE |
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional | Pegavision Corporation | 05/21/2026SE |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Special | Pegavision Corporation | 05/19/2026SE |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…LPL · Traditional | Geo Medical Co., Ltd. | 04/29/2026SE |
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | St. shine Optical Co., Ltd. | 03/19/2026SE |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional | Pegavision Corporation | 03/13/2026SE |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional | Alcon Laboratories, Inc. | 02/13/2026SE |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…LPL · Traditional | Bruno Vision Care, LLC | 12/23/2025SE |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | St. shine Optical Co., Ltd. | 10/07/2025SE |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…LPL · Traditional | Yung Sheng Optical Co., Ltd. | 09/25/2025SE |
More from Yung Sheng Optical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Traditional | 08/13/2026SE |
| K193399 | Miru 1day UpSide (midafilcon A)LPL · Traditional | 06/17/2020SE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPN · Traditional | 03/02/2020SE |
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact LensLPL · Traditional | 02/22/2018SE |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMRC · Traditional | 11/16/2017SE |
| K151768 | Menicon Saline Rinse SolutionLPN · Traditional | 08/28/2015SE |
| K130805 | Menicon Unique PH Multi-Purpose SolutionMRC · Traditional | 07/03/2013SE |
| K122273 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensMRC · Abbreviated | 01/02/2013SE |
| K102895 | One Day Flat PackLPL · Traditional | 04/28/2011SE |
| K103561 | Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensHQD · Traditional | 02/03/2011SE |
Questions and answers
When was One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens cleared by the FDA?
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (K180819) received a 510(k) decision of Substantially Equivalent on May 16, 2018, 48 days after the submission was received.
What is the product code of K180819?
The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.