Cleared Traditional

K983278 - OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) (FDA 510(k) Clearance)

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

K983278 · Alden Optical Labs., Inc. · Ophthalmic device
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Nov 1998
Decision
69d
Days
Class 2
Risk

K983278 is an FDA 510(k) clearance for the OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LE.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Alden Optical Labs., Inc. (Grand Junction, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alden Optical Labs., Inc. devices

Submission Details

510(k) Number K983278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1998
Decision Date November 25, 1998
Days to Decision 69 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
41d faster than avg
Panel avg: 110d · This submission: 69d
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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