Cleared Traditional

K973192 - FLEXLENS, FLEXLENS TORIC

K973192 is an FDA 510(k) clearance for FLEXLENS, manufactured by Specialty Ultravision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K973192 · Specialty Ultravision, Inc. · Ophthalmic device
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Nov 1997
Decision
87d
Days
Class 2
Risk

K973192 is an FDA 510(k) clearance for the FLEXLENS, FLEXLENS TORIC. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Specialty Ultravision, Inc. (Freehold, US). The FDA issued a Cleared decision on November 20, 1997 after a review of 87 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 Specialty Ultravision, Inc. devices

FDA 510(k) Submission Details - K973192

510(k) Number K973192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1997
Decision Date November 20, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
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 191
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K973192.
PREFERENCE 60 AND PREFERENCE 60 TORIC
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K973967 · Alden Optical Labs., Inc. · Dec 1997
AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS
K973597 · Martin Dalsing · Nov 1997
(LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI
K972807 · Benz Research and Development Corp. · Oct 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
K973063 · Aspect Vision Care, Ltd. · Aug 1997