Cleared Traditional

K120904 - POLARIS DIAL-A-DATE CONTACT LENS CASE

K120904 is an FDA 510(k) clearance for POLARIS DIAL-A-DATE CONTACT LENS CASE, manufactured by Reliance Design & Manufacture Corp.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K120904 · Reliance Design & Manufacture Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
245d
Days
Class 2
Risk

K120904 is an FDA 510(k) clearance for the POLARIS DIAL-A-DATE CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Reliance Design & Manufacture Corp. (Austin, US). The FDA issued a Cleared decision on November 26, 2012 after a review of 245 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.

FDA 510(k) Submission Details - K120904

510(k) Number K120904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date November 26, 2012
Days to Decision 245 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
135d slower than avg
Panel avg: 110d · This submission: 245d
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 K120904.
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
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
K130285 · The Lagado Corp. · Apr 2013
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
EYE CARE CURE CONTACT LENS CASE
K112832 · Eye Care and Cure · Dec 2011
K120904 · POLARIS DIAL-A-DATE CONTACT LENS CASE
Download PDF FDA Summary Reliance Design & Man…