Cleared Traditional

K972303 - OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS

K972303 is an FDA 510(k) clearance for OSCULAR SCIENCES/ AMERICAN HYDRON, manufactured by Ocular Sciences Puerto Rico, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K972303 · Ocular Sciences Puerto Rico, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
62d
Days
Class 2
Risk

K972303 is an FDA 510(k) clearance for the OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Ocular Sciences Puerto Rico, Inc. (Cupertino, US). The FDA issued a Cleared decision on August 20, 1997 after a review of 62 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 Ocular Sciences Puerto Rico, Inc. devices

FDA 510(k) Submission Details - K972303

510(k) Number K972303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1997
Decision Date August 20, 1997
Days to Decision 62 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
48d faster than avg
Panel avg: 110d · This submission: 62d
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 191
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K972303.
AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
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K972807 · Benz Research and Development Corp. · Oct 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
K973063 · Aspect Vision Care, Ltd. · Aug 1997
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K972454 · Bausch & Lomb, Inc. · Aug 1997
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K971647 · Lombart Lenses, Ltd. · Jul 1997
FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
K971049 · Aspect Vision Care, Ltd. · May 1997