Cleared Traditional

K240095 - CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (FDA 510(k) Clearance)

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

K240095 · Shanghai Care US Medical Product Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
271d
Days
Class 2
Risk

K240095 is an FDA 510(k) clearance for the CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6). Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Shanghai Care US Medical Product Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 9, 2024 after a review of 271 days - an extended review cycle.

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 Shanghai Care US Medical Product Co., Ltd. devices

Submission Details

510(k) Number K240095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2024
Decision Date October 09, 2024
Days to Decision 271 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 110d · This submission: 271d
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.