Cleared Traditional

K231123 - Phoenix Contact Lens Case - dome top flat pack (CL-01) (FDA 510(k) Clearance)

Also includes:
Phoenix Contact Lens Case - classic flat pack (CL-02) Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
132d
Days
Class 2
Risk

K231123 is an FDA 510(k) clearance for the Phoenix Contact Lens Case - dome top flat pack (CL-01). Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. (Navi Mumbai, IN). The FDA issued a Cleared decision on August 30, 2023 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. devices

Submission Details

510(k) Number K231123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 110d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.