Cleared Traditional

K193399 - Miru 1day UpSide (midafilcon A)

K193399 is an FDA 510(k) clearance for Miru 1day UpSide (midafilcon A), manufactured by Menicon Co, Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K193399 · Menicon Co, Ltd. · Ophthalmic device
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Jun 2020
Decision
194d
Days
Class 2
Risk

K193399 is an FDA 510(k) clearance for the Miru 1day UpSide (midafilcon A). 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 June 17, 2020 after a review of 194 days - an extended review 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: 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 Menicon Co, Ltd. devices

FDA 510(k) Submission Details - K193399

510(k) Number K193399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2019
Decision Date June 17, 2020
Days to Decision 194 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
84d slower than avg
Panel avg: 110d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

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 Peers - LPL Lenses, Soft Contact, Daily Wear

All 291
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K193399.
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K201080 · Visco Vision, Inc. · Jul 2020
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
K200528 · Bausch & Lomb, Incorporated · Jun 2020
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ACUVUE (senofilcon A) Soft Contact Lens Multifocal
K200243 · Johnson & Johnson Vision Care, Inc. · Mar 2020