Cleared Traditional

K943490 - CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES

K943490 is an FDA 510(k) clearance for CONTINENTAL 45 (HEFILCON A) SPHERICAL &..., 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 23-day FDA review.

K943490 · Continental Soft Lens, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
23d
Days
Class 2
Risk

K943490 is an FDA 510(k) clearance for the CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES. 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 August 11, 1994 after a review of 23 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 - K943490

510(k) Number K943490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date August 11, 1994
Days to Decision 23 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
87d faster than avg
Panel avg: 110d · This submission: 23d
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 K943490.
OCU-FLEX-38 (POLYMACON)
K941998 · Ocu-Ease Optical Products, Inc. · Oct 1994
PRECISION UV(TM) (VASURFILCON A)
K944722 · Pilkington Barnes-Hind, Ltd. · Oct 1994
LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS
K942494 · Permeable Technologies, Inc. · Sep 1994
ADDVANTAGE 38 ASPHERIC SOFT CONTACT LENS
K942302 · Preferred Optics, Inc. · Aug 1994
ESSTECH PS ASPHERIC
K942186 · Szabocsik and Assoc. · Jul 1994
ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K942187 · Szabocsik and Assoc. · Jul 1994
K943490 · CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES
Download PDF FDA Summary Continental Soft Lens…