Cleared Traditional

ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR (K983160) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983160 · Hydron , Ltd. · Ophthalmic device
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Feb 1999
Decision
162d
Days
Class 2
Risk

K983160 is an FDA 510(k) clearance for the ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Hydron , Ltd. (Farnborough, Hants, GB). The FDA issued a Cleared decision on February 18, 1999 after a review of 162 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 Hydron , Ltd. devices

Submission Details

510(k) Number K983160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1998
Decision Date February 18, 1999
Days to Decision 162 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
52d slower than avg
Panel avg: 110d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 485
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