Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
Summary
X-Cel Specialty Contacts, A Walman Optical Company received 510(k) clearance for Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A), a LPL device. Cleared on 2024-08-14.
Details
Source
510(k) Clearance
External ID
K242059
Action Date
2024-08-14
Status
Special
Category
device
Product Code
LPL
Product Description
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A). Product code: LPL.
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.
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 X-Cel Specialty Contacts, A Walman Optical Company have FDA actions?
This is the only FDA action we have on record for X-Cel Specialty Contacts, A Walman Optical Company in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242059" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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