Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

Lenses, Soft Contact, Daily Wear

PEGAVISION CORPORATION

The following data is part of a premarket notification filed by Pegavision Corporation with the FDA for Aquamax (etafilcon A) Bi-weekly Soft, Aquamax (etafilcon A) Daily Disposable Soft (hydrophilic) Contact Lenses.

Pre-market Notification Details

Device IDK161739
510k NumberK161739
Device Name:Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
ClassificationLenses, Soft Contact, Daily Wear
Applicant PEGAVISION CORPORATION 2F-1, NO.5, SHING YEH ST., Taoyuan,  TW 33341
ContactJudith Hou
CorrespondentJudith Hou
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 Received2016-06-24
Decision Date2016-12-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.