Cleared Traditional

K171539 - Contact Lens Case

K171539 is an FDA 510(k) clearance for Contact Lens Case, manufactured by E-Link Plastic & Metal Industrial Co.,Ltd. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K171539 · E-Link Plastic & Metal Industrial Co.,Ltd · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
49d
Days
Class 2
Risk

K171539 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 E-Link Plastic & Metal Industrial Co.,Ltd (New Taipei, CN). The FDA issued a Cleared decision on July 14, 2017 after a review of 49 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 E-Link Plastic & Metal Industrial Co.,Ltd devices

FDA 510(k) Submission Details - K171539

510(k) Number K171539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2017
Decision Date July 14, 2017
Days to Decision 49 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
61d faster than avg
Panel avg: 110d · This submission: 49d
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 Consultant

Shenzhen Hlongmed Biotech Company
Long Yang

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 38
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K171539.
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K173538 · Alcon Laboratories, Inc. · Dec 2017
Contact Lens Case, Model: A-1, B-1
K172925 · P L Overseas Limited · Nov 2017
Bausch + Lomb Boston Scleral Lens Case
K173365 · Bausch & Lomb, Incorporated · Nov 2017
Contact Lens Case Round Glasses
K171163 · Fiftytwoways, Ltd. · Jun 2017
Contact Lens Case
K162869 · Ningbo Yinzhou Zonghai Artware Co., Ltd. · Dec 2016
Contact Lens Case (multiple brand name)
K160005 · Danyang Chanxin Glasses Cases Factory · Jun 2016