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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 67
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K130285.
MENICON NECT CONTACT LENS CASE
K131875 · Foresight Regulatory Strategies · Aug 2013
STANDARD CONTACT LENS CASE
K130753 · Watchdog Group, LC · Jun 2013
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
K122700 · Prosben, Inc. · May 2013
POLARIS DIAL-A-DATE CONTACT LENS CASE
K120904 · Reliance Design & Manufacture Corp. · Nov 2012
AC LENS BRANDED CONTACT LENS CASE
K120969 · Arlington Contact Lens Services,Inc. · Jul 2012
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
K121030 · Sacks Holdings, Inc. · Jul 2012
K130285 · PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
Download PDF FDA Summary The Lagado Corp.