Cleared Traditional

LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (K120821) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120821 · Misder, LLC · Gastroenterology & Urology device
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May 2012
Decision
53d
Days
Class 2
Risk

K120821 is an FDA 510(k) clearance for the LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Misder, LLC (Golden, US). The FDA issued a Cleared decision on May 11, 2012 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Misder, LLC devices

Submission Details

510(k) Number K120821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2012
Decision Date May 11, 2012
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 130d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCT Anti Fog Solution And Accessories, Endoscopy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCT Anti Fog Solution And Accessories, Endoscopy

All 26
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K120821.
KnoxFog Anti-fogging Device
K251068 · Uv One Hygienics, Inc. · Aug 2025
GOLFF Sterile Anti-Fog Solution
K231822 · Batrik Medical Manufacturing, Inc. · Feb 2024
E-Brik Visualization Assistant
K221293 · Jdi Surgical, Inc. · Jul 2022
Konix Anti-Fog Solution
K190864 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · Aug 2020
AMD Anti-Fog Solution
K181887 · Advanced Medical Design Co., Ltd. · Jan 2019