Cleared Traditional

K990011 - CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

K990011 is an FDA 510(k) clearance for CONTINENTAL 45 TORIC SOFT (HYDROPHILIC)..., manufactured by Continental Soft Lens, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K990011 · Continental Soft Lens, Inc. · Ophthalmic device
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May 1999
Decision
127d
Days
Class 2
Risk

K990011 is an FDA 510(k) clearance for the CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Continental Soft Lens, Inc. (Littleton, US). The FDA issued a Cleared decision on May 11, 1999 after a review of 127 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 Continental Soft Lens, Inc. devices

FDA 510(k) Submission Details - K990011

510(k) Number K990011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1999
Decision Date May 11, 1999
Days to Decision 127 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
17d slower than avg
Panel avg: 110d · This submission: 127d
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 279
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K990011.
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
ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS
K984098 · Adventures IN Color Technology, Ltd. · May 1999
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
K991134 · Vistakon, Johnson & Johnson Vision Products, Inc. · May 1999
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA
K990757 · Cantor & Silver , Ltd. · Apr 1999