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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K090362.
EYE CARE CURE CONTACT LENS CASE
K112832 · Eye Care and Cure · Dec 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
K111856 · Apothecary Products, Inc. · Jul 2011
POLARIS CONTACT LENS CASE
K093377 · Reliance Design & Manufacturing Corp. · Apr 2010
CONTACT LENS CASE
K071081 · Ningbo Kaida Rubber and Plastic Technology Co., LT · May 2007
SAUFLON FLAT COLOURED LENS CASE
K052809 · Sauflon Pharmaceuticals, Ltd. · Nov 2005
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
K090362 · IMAG, IPOD, EZ-FIND AND ISLIDE
Download PDF FDA Summary Voguestrap