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
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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.

View all Viopti, Ltd. devices

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
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 14
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K131783.
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Aug 2023
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K173538 · Alcon Laboratories, Inc. · Dec 2017
Bausch + Lomb Boston Scleral Lens Case
K173365 · Bausch & Lomb, Incorporated · Nov 2017
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
CYBERCASES BY BAUSCH & LOMB
K013232 · Bausch & Lomb, Inc. · Nov 2001
ALCON CONTACT LENS CASE
K974281 · Alcon Laboratories · Jan 1998