Cleared Traditional

K171163 - Contact Lens Case Round Glasses

K171163 is an FDA 510(k) clearance for Contact Lens Case Round Glasses, manufactured by Fiftytwoways, Ltd.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K171163 · Fiftytwoways, Ltd. · Ophthalmic device
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Jun 2017
Decision
68d
Days
Class 2
Risk

K171163 is an FDA 510(k) clearance for the Contact Lens Case Round Glasses. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Fiftytwoways, Ltd. (Kwai Chung, HK). The FDA issued a Cleared decision on June 27, 2017 after a review of 68 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 Fiftytwoways, Ltd. devices

FDA 510(k) Submission Details - K171163

510(k) Number K171163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2017
Decision Date June 27, 2017
Days to Decision 68 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
42d faster than avg
Panel avg: 110d · This submission: 68d
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 38
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K171163.
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
K171539 · E-Link Plastic & Metal Industrial Co.,Ltd · Jul 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
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
K142717 · Ni Hau Industrial Co., Ltd. · May 2015