Cleared Traditional

K211361 - 3N Contact Lenses Adjunct Cleaner

K211361 is an FDA 510(k) clearance for 3N Contact Lenses Adjunct Cleaner, manufactured by Suzhou 3N Biological Technology Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LYL cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K211361 · Suzhou 3N Biological Technology Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
255d
Days
Class 2
Risk

K211361 is an FDA 510(k) clearance for the 3N Contact Lenses Adjunct Cleaner. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Suzhou 3N Biological Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on January 13, 2022 after a review of 255 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 Suzhou 3N Biological Technology Co., Ltd. devices

FDA 510(k) Submission Details - K211361

510(k) Number K211361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date January 13, 2022
Days to Decision 255 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
145d slower than avg
Panel avg: 110d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYL Device Classification - Class 2, Special Controls

Product Code LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
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 - LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

Devices cleared under the same product code (LYL) and FDA review panel - the closest regulatory comparables to K211361.
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
K210300 · Vuesonic, LLC · Apr 2021
BPZ02 MULTIPURPOSE SOLUTION
K083757 · Bausch & Lomb, Inc. · Nov 2009
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · Ciba Vision Corporation · Nov 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
K020802 · Bausch & Lomb, Incorporated · May 2002