Cleared Traditional

K993252 - METHAFILCON A SOFT HYDROPHILIC CONTACT ...

K993252 is the FDA 510(k) clearance for METHAFILCON A SOFT HYDROPHILIC CONTACT ... by CooperVision, Inc.. It is a Class 2 Ophthalmic device (product code MVN) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K993252 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
57d
Days
Class 2
Risk

K993252 is an FDA 510(k) clearance for the METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV .... Classified as Lens, Contact, (disposable) (product code MVN), Class II - Special Controls.

Submitted by CooperVision, Inc. (Scottsville,, US). The FDA issued a Cleared decision on November 24, 1999 after a review of 57 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 CooperVision, Inc. devices

Submission Details

510(k) Number K993252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1999
Decision Date November 24, 1999
Days to Decision 57 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVN Lens, Contact, (disposable)
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 - MVN Lens, Contact, (disposable)

All 12
Devices cleared under the same product code (MVN) and FDA review panel - the closest regulatory comparables to K993252.
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
K011718 · Bausch & Lomb, Inc. · Jul 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
K010636 · Ciba Vision Corporation · Mar 2001
FOCUS DAILIES PROGRESSIVES
K003826 · Ciba Vision Corporation · Mar 2001
FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS
K984273 · Ciba Vision Corporation · Jan 1999