Cleared Traditional

K160005 - Contact Lens Case (multiple brand name)

K160005 is an FDA 510(k) clearance for Contact Lens Case (multiple brand name), manufactured by Danyang Chanxin Glasses Cases Factory. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K160005 · Danyang Chanxin Glasses Cases Factory · Ophthalmic device
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Jun 2016
Decision
155d
Days
Class 2
Risk

K160005 is an FDA 510(k) clearance for the Contact Lens Case (multiple brand name). Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Danyang Chanxin Glasses Cases Factory (Danyang City, CN). The FDA issued a Cleared decision on June 7, 2016 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Danyang Chanxin Glasses Cases Factory devices

FDA 510(k) Submission Details - K160005

510(k) Number K160005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2016
Decision Date June 07, 2016
Days to Decision 155 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
45d slower than avg
Panel avg: 110d · This submission: 155d
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

Osmunda Medical Device Service Group
MIKE GU

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 K160005.
Contact Lens Case
K171539 · E-Link Plastic & Metal Industrial Co.,Ltd · Jul 2017
Contact Lens Case Round Glasses
K171163 · Fiftytwoways, Ltd. · Jun 2017
Contact Lens Case
K162869 · Ningbo Yinzhou Zonghai Artware Co., Ltd. · Dec 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
iCase Contact Lens Case
K143351 · Novabay Pharmaceuticals, Inc. · Apr 2015
CONTACT LENS CASE
K140488 · Maca Plastics, Inc. · Sep 2014