Cleared Traditional

K130753 - STANDARD CONTACT LENS CASE

Also marketed or referenced as:
FLIP N SLIDE CONTACT LENS CASE

K130753 is an FDA 510(k) clearance for STANDARD CONTACT LENS CASE, manufactured by Watchdog Group, LC. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K130753 · Watchdog Group, LC · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
86d
Days
Class 2
Risk

K130753 is an FDA 510(k) clearance for the STANDARD CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Watchdog Group, LC (Clayton, US). The FDA issued a Cleared decision on June 13, 2013 after a review of 86 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 - K130753

510(k) Number K130753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2013
Decision Date June 13, 2013
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
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 K130753.
POLAROID CONTACTSPOD
K131783 · Viopti, Ltd. · Feb 2014
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
K130930 · Ningbo Lishunda Electronics Co., Ltd. · Feb 2014
MENICON NECT CONTACT LENS CASE
K131875 · Foresight Regulatory Strategies · Aug 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
POLARIS DIAL-A-DATE CONTACT LENS CASE
K120904 · Reliance Design & Manufacture Corp. · Nov 2012
K130753 · STANDARD CONTACT LENS CASE
Download PDF FDA Summary Watchdog Group, LC