Cleared Traditional

K071081 - CONTACT LENS CASE

K071081 is an FDA 510(k) clearance for CONTACT LENS CASE, manufactured by Ningbo Kaida Rubber and Plastic Technology Co., LT. 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.

K071081 · Ningbo Kaida Rubber and Plastic Technology Co., LT · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
14d
Days
Class 2
Risk

K071081 is an FDA 510(k) clearance for the CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Ningbo Kaida Rubber and Plastic Technology Co., LT (Shanghai, CN). The FDA issued a Cleared decision on May 1, 2007 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 - K071081

510(k) Number K071081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2007
Decision Date May 01, 2007
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.
MARC M MOUSER

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 81
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K071081.
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
IMAG, IPOD, EZ-FIND AND ISLIDE
K090362 · Voguestrap · Feb 2009
SAUFLON FLAT COLOURED LENS CASE
K052809 · Sauflon Pharmaceuticals, Ltd. · Nov 2005
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
I-PROMOTIONS CONTACT LENS CASE
K042578 · I-Promotions, Inc. · Jan 2005
K071081 · CONTACT LENS CASE
Download PDF FDA Summary Ningbo Kaida Rubber a…