Cleared Traditional

K991000 - GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES

K991000 is an FDA 510(k) clearance for GENTLE TOUCH UV (NETRAFILCON A) SOFT CO..., manufactured by Wesley Jessen Corp.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K991000 · Wesley Jessen Corp. · Ophthalmic device
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Jun 1999
Decision
96d
Days
Class 2
Risk

K991000 is an FDA 510(k) clearance for the GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Wesley Jessen Corp. (Des Plaines, US). The FDA issued a Cleared decision on June 28, 1999 after a review of 96 days - within the typical 510(k) review window.

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 Wesley Jessen Corp. devices

FDA 510(k) Submission Details - K991000

510(k) Number K991000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1999
Decision Date June 28, 1999
Days to Decision 96 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
14d faster than avg
Panel avg: 110d · This submission: 96d
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 357
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K991000.
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A)
K984090 · Specialty Ultravision, Inc. · Jul 1999
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
K992054 · Adventures IN Color Technology, Ltd. · Jul 1999
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)
K992010 · Westcon Contact Lens Co., Inc. · Jun 1999
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
K991163 · Vistakon, Johnson & Johnson Vision Products, Inc. · Jun 1999
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
K990815 · Colorsoft Laboratories Corp. · Jun 1999
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS
K991550 · Wesley Jessen Corp. · May 1999