Submission Details
| 510(k) Number | K244009 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 26, 2024 |
| Decision Date | September 25, 2025 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
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)
Sep 2025
Decision
273d
Days
Class 2
Risk
About This 510(k) Submission
K244009 is an FDA 510(k) clearance for the 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), a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Yung Sheng Optical Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on September 25, 2025, 273 days after receiving the submission on December 26, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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