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510(k) K242059

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) by X-Cel Specialty Contacts, A Walman Optical Company — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2024
Date Received
July 15, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

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