Cleared Traditional

K080512 - REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT

K080512 is an FDA 510(k) clearance for REVITALEYES, manufactured by Metro Optics of Austin, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K080512 · Metro Optics of Austin, Inc. · Ophthalmic device
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Jul 2008
Decision
149d
Days
Class 2
Risk

K080512 is an FDA 510(k) clearance for the REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Metro Optics of Austin, Inc. (Grand Junction, US). The FDA issued a Cleared decision on July 23, 2008 after a review of 149 days - within the typical 510(k) review window.

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 Metro Optics of Austin, Inc. devices

FDA 510(k) Submission Details - K080512

510(k) Number K080512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date July 23, 2008
Days to Decision 149 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
39d slower than avg
Panel avg: 110d · This submission: 149d
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 458
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K080512.
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K080794 · Polyvue Distribution, Inc. · Dec 2008
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · CooperVision, Inc. · Sep 2008
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K082393 · Unilens Corp., USA · Sep 2008
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
K073621 · Art Optical Contact Lens, Inc. · Jul 2008
WESTCON HORIZON 49% (HIOXIFILCON B)
K080686 · Westcon Contact Lens Co. · Apr 2008
VISTAKON (NARAFILCON) A SOFT CONTACT LENS
K073485 · Johnson & Johnson Vision Care, Inc. · Mar 2008