Cleared Traditional

Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)

K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Ophthalmic

Aug 2023

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K231123 is an FDA 510(k) clearance for the Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03), a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. (Navi Mumbai, IN). The FDA issued a Cleared decision on August 30, 2023, 132 days after receiving the submission on April 20, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K231123 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2023
Decision Date	August 30, 2023
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF