Cleared Traditional

K133403 - FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES

K133403 is an FDA 510(k) clearance for FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, manufactured by Firestone Optics, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K133403 · Firestone Optics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
217d
Days
Class 2
Risk

K133403 is an FDA 510(k) clearance for the FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT L.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Firestone Optics, Inc. (Grand Junction, US). The FDA issued a Cleared decision on June 11, 2014 after a review of 217 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.

View all Firestone Optics, Inc. devices

FDA 510(k) Submission Details - K133403

510(k) Number K133403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2013
Decision Date June 11, 2014
Days to Decision 217 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
107d slower than avg
Panel avg: 110d · This submission: 217d
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 170
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K133403.
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K132715 · Bausch & Lomb, Incorporated · Dec 2013