Cleared Traditional

K060821 - SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES

K060821 is an FDA 510(k) clearance for SPECIALEYES 50 AND SPECIALEYES 49 SHPER..., manufactured by Specialeyes, LLC. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K060821 · Specialeyes, LLC · Ophthalmic device
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May 2006
Decision
52d
Days
Class 2
Risk

K060821 is an FDA 510(k) clearance for the SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Specialeyes, LLC (Appollo Beach, US). The FDA issued a Cleared decision on May 18, 2006 after a review of 52 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 Specialeyes, LLC devices

FDA 510(k) Submission Details - K060821

510(k) Number K060821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2006
Decision Date May 18, 2006
Days to Decision 52 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
58d faster than avg
Panel avg: 110d · This submission: 52d
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 282
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K060821.
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K072777 · Ciba Vision Corporation · Jan 2008
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K071736 · CooperVision, Inc. · Jan 2008
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
K062262 · Ciba Vision Corporation · Nov 2006
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · CooperVision, Inc. · Dec 2005
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K050948 · Bausch & Lomb, Inc. · May 2005
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
K050717 · CooperVision, Inc. · May 2005