Cleared Traditional

K121324 - AVT NATURASOFT

K121324 is an FDA 510(k) clearance for AVT NATURASOFT, manufactured by Advanced Vision Technologies. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K121324 · Advanced Vision Technologies · Ophthalmic device
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Aug 2012
Decision
113d
Days
Class 2
Risk

K121324 is an FDA 510(k) clearance for the AVT NATURASOFT. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Advanced Vision Technologies (Grand Junction, US). The FDA issued a Cleared decision on August 23, 2012 after a review of 113 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 Advanced Vision Technologies devices

FDA 510(k) Submission Details - K121324

510(k) Number K121324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2012
Decision Date August 23, 2012
Days to Decision 113 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
3d slower than avg
Panel avg: 110d · This submission: 113d
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 350
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K121324.
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K110835 · GEO MEDICAL CO., LTD. · Apr 2012