Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
Summary
CooperVision, Inc. received 510(k) clearance for Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker, a LPL device. Cleared on 2024-01-25.
Details
Source
510(k) Clearance
External ID
K234127
Action Date
2024-01-25
Status
Special
Category
device
Product Code
LPL
Product Description
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker. 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. CooperVision, Inc. has received 3 total clearances in our database.
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 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 CooperVision, Inc. have FDA actions?
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K234127" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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