Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

Lenses, Soft Contact, Daily Wear

Plexus Optix, Inc.

The following data is part of a premarket notification filed by Plexus Optix, Inc. with the FDA for Ethos Aquell (hioxifilcon A) One-day Soft (hydrophilic) Contact Lenses (59% Water).

Pre-market Notification Details

Device IDK201268
510k NumberK201268
Device Name:Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
ClassificationLenses, Soft Contact, Daily Wear
Applicant Plexus Optix, Inc. 3333 Quality Drive Rancho Cordova,  CA  95670
ContactDave Delle Donne
CorrespondentEstela Lin
Pegavision Corporation 2F-1, No.5, Shing Yeh St. Taoyuan,  TW 33341
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-12
Decision Date2020-10-21

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