Cleared Traditional

K003526 - SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)

K003526 is an FDA 510(k) clearance for SPECIALTY 55 UV (METHAFILCON A) SOFT (H..., manufactured by Specialty Ultravision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K003526 · Specialty Ultravision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
88d
Days
Class 2
Risk

K003526 is an FDA 510(k) clearance for the SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEA.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Specialty Ultravision, Inc. (Campbell, US). The FDA issued a Cleared decision on February 12, 2001 after a review of 88 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.

FDA 510(k) Submission Details - K003526

510(k) Number K003526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2000
Decision Date February 12, 2001
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K003526.
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT
K004000 · Ocu-Ease Optical Products, Inc. · Feb 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE
K001585 · American Biocurve, Inc. · Feb 2001
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
K003833 · Clearlab Pte , Ltd. · Feb 2001
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT
K003042 · Joe B. Goldberg, O.D. · Jan 2001
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
K003136 · Ocular Sciences Puerto Rico, Inc. · Jan 2001
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT
K003161 · Les Laboratoires Blanchard · Dec 2000
K003526 · SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)
Download PDF FDA Summary Specialty Ultravision…