Cleared Traditional

K980197 - ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR

K980197 is an FDA 510(k) clearance for ULTRACON/ULTRACON S RIGID GAS PERMEABLE..., manufactured by Specialty Ultravision, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K980197 · Specialty Ultravision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
196d
Days
Class 2
Risk

K980197 is an FDA 510(k) clearance for the ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Specialty Ultravision, Inc. (Campbell, US). The FDA issued a Cleared decision on August 4, 1998 after a review of 196 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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.

FDA 510(k) Submission Details - K980197

510(k) Number K980197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date August 04, 1998
Days to Decision 196 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
86d slower than avg
Panel avg: 110d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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 - HQD Lens, Contact (other Material) - Daily

All 115
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K980197.
PVS BASICS
K984436 · Paragon Vision Sciences · Apr 1999
OXYCON LENS
K990895 · Concise Contact Lens Co. · Apr 1999
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS
K990264 · Metro Optics of Austin, Inc. · Mar 1999
BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
K980741 · Polymer Technology Div. Wilmington Partners, L.P. · May 1998
FLOSI RIGID GAS PERMEABLE CONTACT LENS
K974636 · Futuristic Design Assoc. · Mar 1998
MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K972443 · Menicon U.S.A., Inc. · Aug 1997
K980197 · ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR
Download PDF FDA Summary Specialty Ultravision…