Cleared Traditional

K042435 - COOPER PROSTHETIC

K042435 is an FDA 510(k) clearance for COOPER PROSTHETIC, manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K042435 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Oct 2004
Decision
48d
Days
Class 2
Risk

K042435 is an FDA 510(k) clearance for the COOPER PROSTHETIC. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Scottsville,, US). The FDA issued a Cleared decision on October 26, 2004 after a review of 48 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

FDA 510(k) Submission Details - K042435

510(k) Number K042435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2004
Decision Date October 26, 2004
Days to Decision 48 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
62d faster than avg
Panel avg: 110d · This submission: 48d
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 348
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K042435.
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS)
K043129 · Opti-Centre Laboratories · Jan 2005
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · CooperVision, Inc. · Nov 2004
VISTAKON (SENOFILCON A) SOFT CONTACT LENS
K042275 · Vistakon · Oct 2004
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
K042242 · Alden Optical Labs., Inc. · Sep 2004
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
K041700 · Cantor & Nissel , Ltd. · Jul 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · CooperVision, Inc. · Jul 2004