Cleared Traditional

Aqua Naina Sterile Saline Solution

K193441 · Chemtex USA, Inc. · Ophthalmic

May 2020

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K193441 is an FDA 510(k) clearance for the Aqua Naina Sterile Saline Solution, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Chemtex USA, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 26, 2020, 167 days after receiving the submission on December 11, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K193441 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2019
Decision Date	May 26, 2020
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF