Cleared Traditional

K090362 - IMAG, IPOD, EZ-FIND AND ISLIDE

K090362 is an FDA 510(k) clearance for IMAG, manufactured by Voguestrap. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K090362 · Voguestrap · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
14d
Days
Class 2
Risk

K090362 is an FDA 510(k) clearance for the IMAG, IPOD, EZ-FIND AND ISLIDE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Voguestrap (Great Neck, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 14 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.

View all Voguestrap devices

FDA 510(k) Submission Details - K090362

510(k) Number K090362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2009
Decision Date February 27, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 15
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K090362.
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
PARAGON LENS CARE
K974635 · Paragon Vision Sciences · Feb 1998