Cleared Traditional

SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) (K011542) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011542 · Specialty Ultravision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
39d
Days
Class 2
Risk

K011542 is an FDA 510(k) clearance for the SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, .... 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 June 26, 2001 after a review of 39 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 Specialty Ultravision, Inc. devices

Submission Details

510(k) Number K011542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2001
Decision Date June 26, 2001
Days to Decision 39 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
71d faster than avg
Panel avg: 110d · This submission: 39d
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 485
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K011542.
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
K260507 · INTEROJO, Inc. · May 2026
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses
K253352 · Pegavision Corporation · May 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K261299 · Pegavision Corporation · May 2026
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS
K253885 · GEO MEDICAL CO., LTD. · Apr 2026
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K254269 · St. shine Optical Co., Ltd. · Mar 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385 · Pegavision Corporation · Mar 2026