Cleared Traditional

K130930 - OWL CONTACT LENS CASES, DOG CONTACT LENS CASES (FDA 510(k) Clearance)

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

K130930 · Ningbo Lishunda Electronics Co., Ltd. · Ophthalmic device
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Feb 2014
Decision
314d
Days
Class 2
Risk

K130930 is an FDA 510(k) clearance for the OWL CONTACT LENS CASES, DOG CONTACT LENS CASES. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Ningbo Lishunda Electronics Co., Ltd. (Pennington, US). The FDA issued a Cleared decision on February 12, 2014 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ningbo Lishunda Electronics Co., Ltd. devices

Submission Details

510(k) Number K130930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2013
Decision Date February 12, 2014
Days to Decision 314 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
204d slower than avg
Panel avg: 110d · This submission: 314d
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.

Regulatory Peers - LRX Case, Contact Lens

All 81
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