Cleared Traditional

K131783 - POLAROID CONTACTSPOD

K131783 is an FDA 510(k) clearance for POLAROID CONTACTSPOD, manufactured by Viopti, Ltd.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K131783 · Viopti, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
249d
Days
Class 2
Risk

K131783 is an FDA 510(k) clearance for the POLAROID CONTACTSPOD. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Viopti, Ltd. (Dumbarton, GB). The FDA issued a Cleared decision on February 21, 2014 after a review of 249 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 - K131783

510(k) Number K131783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2013
Decision Date February 21, 2014
Days to Decision 249 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
139d slower than avg
Panel avg: 110d · This submission: 249d
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 K131783.
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
K142717 · Ni Hau Industrial Co., Ltd. · May 2015
iCase Contact Lens Case
K143351 · Novabay Pharmaceuticals, Inc. · Apr 2015
CONTACT LENS CASE
K140488 · Maca Plastics, Inc. · Sep 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
STANDARD CONTACT LENS CASE
K130753 · Watchdog Group, LC · Jun 2013
K131783 · POLAROID CONTACTSPOD
Download PDF FDA Summary Viopti, Ltd.