Cleared Traditional

K980634 - FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

K980634 is an FDA 510(k) clearance for FREQUENCY UV (ETAFILCON A) HYDROPHILIC ..., manufactured by Aspect Vision Care, Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K980634 · Aspect Vision Care, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
62d
Days
Class 2
Risk

K980634 is an FDA 510(k) clearance for the FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Aspect Vision Care, Ltd. (Freehold, US). The FDA issued a Cleared decision on April 22, 1998 after a review of 62 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.

FDA 510(k) Submission Details - K980634

510(k) Number K980634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1998
Decision Date April 22, 1998
Days to Decision 62 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
48d faster than avg
Panel avg: 110d · This submission: 62d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K980634.
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT
K981779 · Cantor & Silver , Ltd. · Jun 1998
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)
K981252 · Alden Optical Labs., Inc. · Jun 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
K980649 · CooperVision, Inc. · May 1998
PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS
K974408 · Biocompatibles Eyewear, Inc. · Apr 1998
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)
K980554 · Alden Optical Labs., Inc. · Apr 1998
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)
K980818 · Stephen A. Dunn, Inc. · Mar 1998
K980634 · FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
Download PDF FDA Summary Aspect Vision Care, L…