Cleared Special

Aqua Naina Plus Sterile Saline Solution

K221263 · Chemtex USA, Inc. · Ophthalmic

Oct 2022

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K221263 is an FDA 510(k) clearance for the Aqua Naina Plus 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 October 12, 2022, 163 days after receiving the submission on May 2, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K221263 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2022
Decision Date	October 12, 2022
Days to Decision	163 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF