FDA 510(k) Application Details - K242056

Device Classification Name Lenses, Soft Contact, Daily Wear

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510(K) Number K242056
Device Name Lenses, Soft Contact, Daily Wear
Applicant BenQ Materials Corporation
29 Jianguo E. Road, Gueishan
Taoyuan 33341 TW
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Contact Eric Sun
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Regulation Number 886.5925

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Classification Product Code LPL
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Date Received 07/15/2024
Decision Date 04/17/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242056


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