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.
Device ID | K161739 |
510k Number | K161739 |
Device Name: | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | PEGAVISION CORPORATION 2F-1, NO.5, SHING YEH ST., Taoyuan, TW 33341 |
Contact | Judith Hou |
Correspondent | Judith Hou PEGAVISION CORPORATION 2F-1, NO.5, SHING YEH ST., Taoyuan, TW 33341 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-24 |
Decision Date | 2016-12-19 |
Summary: | summary |