One Day Flat Pack
FDA 510(k) K102895 · Menicon Co, Ltd.
510(k) numberK102895
Submission
- Device name
- One Day Flat Pack
- Applicant
- Menicon Co, Ltd.
Grand Junction, CO, US - Received
- September 30, 2010
- Decision date
- April 28, 2011
- 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 |
| K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensLPL · Traditional | 05/16/2018SE |
| 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 |
| K103561 | Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensHQD · Traditional | 02/03/2011SE |
Questions and answers
When was One Day Flat Pack cleared by the FDA?
One Day Flat Pack (K102895) received a 510(k) decision of Substantially Equivalent on April 28, 2011, 210 days after the submission was received.
What is the product code of K102895?
The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.