Submission Details
| 510(k) Number | K232839 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 14, 2023 |
| Decision Date | December 16, 2024 |
| Days to Decision | 459 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
Dec 2024
Decision
459d
Days
Class 2
Risk
About This 510(k) Submission
K232839 is an FDA 510(k) clearance for the Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, 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 December 16, 2024, 459 days after receiving the submission on September 14, 2023. 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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