Cleared Traditional

K102557 - NOVAKONE SPHERICAL AND TORIC LENSES

K102557 is an FDA 510(k) clearance for NOVAKONE SPHERICAL AND TORIC LENSES, manufactured by Alden Optical Labs., Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K102557 · Alden Optical Labs., Inc. · Ophthalmic device
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Apr 2011
Decision
231d
Days
Class 2
Risk

K102557 is an FDA 510(k) clearance for the NOVAKONE SPHERICAL AND TORIC LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Alden Optical Labs., Inc. (Alden, US). The FDA issued a Cleared decision on April 26, 2011 after a review of 231 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K102557

510(k) Number K102557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date April 26, 2011
Days to Decision 231 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 110d · This submission: 231d
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 K102557.
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
K110261 · Soflex Limited · Jul 2011
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
K110099 · CooperVision, Inc. · Jun 2011
ONE DAY FLAT PACK
K102895 · Menicon Co, Ltd. · Apr 2011
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
K110452 · Unilens Corp., USA · Apr 2011
METRO SOFT
K100244 · Metro Optics of Austin, Inc. · Oct 2010
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
K100443 · X-Cel Contacts, Inc. · Oct 2010
K102557 · NOVAKONE SPHERICAL AND TORIC LENSES
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