Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily
Summary
Yung Sheng Optical Co., Ltd. received 510(k) clearance for Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, a LPL device. Cleared on 2024-12-16.
Details
Source
510(k) Clearance
External ID
K232839
Action Date
2024-12-16
Status
Traditional
Category
device
Product Code
LPL
Product Description
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear. Product code: LPL.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Yung Sheng Optical Co., Ltd. has received 3 total clearances in our database.
Yung Sheng Optical Co., Ltd. has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Yung Sheng Optical Co., Ltd. have FDA actions?
Yung Sheng Optical Co., Ltd. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232839" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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