Cleared Traditional

K112832 - EYE CARE CURE CONTACT LENS CASE

K112832 is an FDA 510(k) clearance for EYE CARE CURE CONTACT LENS CASE, manufactured by Eye Care and Cure. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K112832 · Eye Care and Cure · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
67d
Days
Class 2
Risk

K112832 is an FDA 510(k) clearance for the EYE CARE CURE CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Eye Care and Cure (Tucson, US). The FDA issued a Cleared decision on December 5, 2011 after a review of 67 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 - K112832

510(k) Number K112832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2011
Decision Date December 05, 2011
Days to Decision 67 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
43d faster than avg
Panel avg: 110d · This submission: 67d
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 K112832.
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
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
K111856 · Apothecary Products, Inc. · Jul 2011
POLARIS CONTACT LENS CASE
K093377 · Reliance Design & Manufacturing Corp. · Apr 2010
IMAG, IPOD, EZ-FIND AND ISLIDE
K090362 · Voguestrap · Feb 2009
K112832 · EYE CARE CURE CONTACT LENS CASE
Download PDF FDA Summary Eye Care and Cure