Cleared Traditional

K962185 - HYDRASOFT (EAST) AND HYDRASOFT TORIC(EA...

K962185 is the FDA 510(k) clearance for HYDRASOFT (EAST) AND HYDRASOFT TORIC(EA... by CooperVision, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K962185 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
194d
Days
Class 2
Risk

K962185 is an FDA 510(k) clearance for the HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HY.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Fairport, US). The FDA issued a Cleared decision on December 17, 1996 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 CooperVision, Inc. devices

Submission Details

510(k) Number K962185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1996
Decision Date December 17, 1996
Days to Decision 194 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
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 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K962185.
PREFERENCE 60 AND PREFERENCE 60 TORIC
K963013 · CooperVision, Inc. · Dec 1997
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K972454 · Bausch & Lomb, Inc. · Aug 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746 · Ciba Vision Corporation · May 1997
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