Cleared Traditional

K180004 - Menicon ASRB (asmofilcon A) Silicone Hy...

K180004 is the FDA 510(k) clearance for Menicon ASRB (asmofilcon A) Silicone Hy... by Menicon Co, Ltd.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K180004 · Menicon Co, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
51d
Days
Class 2
Risk

K180004 is an FDA 510(k) clearance for the Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on February 22, 2018 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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 Menicon Co, Ltd. devices

Submission Details

510(k) Number K180004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date February 22, 2018
Days to Decision 51 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
59d faster than avg
Panel avg: 110d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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

Foresight Regulatory Stategies, Inc.
Ellen M. Beucler

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 - LPL Lenses, Soft Contact, Daily Wear

All 139
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K180004.
ACUVUE OASYS (senofilcon A) with Photochromic Additive
K180299 · Johnson & Johnson Vision Care, Inc. · Apr 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
K180398 · Alcon Laboratories, Inc. · Apr 2018
OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
K173958 · Visco Vision, Inc. · Apr 2018
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · CooperVision, Inc. · Jul 2016
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · CooperVision, Inc. · Dec 2013
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
K131208 · Bausch & Lomb, Inc. · Sep 2013