Cleared Traditional

Miru 1day UpSide (midafilcon A) (K193399) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 Peers - LPL Lenses, Soft Contact, Daily Wear

All 485
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