Cleared Traditional

K130285 - PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS

K130285 is an FDA 510(k) clearance for PROGENT LARGE DIAMETER CONTACT LENS CAS..., manufactured by The Lagado Corp.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K130285 · The Lagado Corp. · Ophthalmic device
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Apr 2013
Decision
57d
Days
Class 2
Risk

K130285 is an FDA 510(k) clearance for the PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by The Lagado Corp. (Wilmington, US). The FDA issued a Cleared decision on April 3, 2013 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Lagado Corp. devices

FDA 510(k) Submission Details - K130285

510(k) Number K130285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date April 03, 2013
Days to Decision 57 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
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K130285.
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K013232 · Bausch & Lomb, Inc. · Nov 2001
ALCON CONTACT LENS CASE
K974281 · Alcon Laboratories · Jan 1998