Cleared Traditional

K961606 - METRO FOCAL ASPHERIC (POLYMACON)

K961606 is an FDA 510(k) clearance for METRO FOCAL ASPHERIC (POLYMACON), manufactured by Metro Optics of Austin, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K961606 · Metro Optics of Austin, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Nov 1996
Decision
209d
Days
Class 2
Risk

K961606 is an FDA 510(k) clearance for the METRO FOCAL ASPHERIC (POLYMACON). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Metro Optics of Austin, Inc. (Rosewell, US). The FDA issued a Cleared decision on November 20, 1996 after a review of 209 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 Metro Optics of Austin, Inc. devices

FDA 510(k) Submission Details - K961606

510(k) Number K961606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1996
Decision Date November 20, 1996
Days to Decision 209 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
99d slower than avg
Panel avg: 110d · This submission: 209d
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 165
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K961606.
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746 · Ciba Vision Corporation · May 1997
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
K962185 · CooperVision, Inc. · Dec 1996
DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS
K963487 · Ciba Vision Corporation · Nov 1996
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · CooperVision, Inc. · Nov 1995
TETRAFILCON A HYDROPHILIC CONTACT LENSES
K950968 · CooperVision, Inc. · Jul 1995
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895 · Bausch & Lomb, Inc. · Dec 1994