Cleared Traditional

K980741 - BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)

K980741 is an FDA 510(k) clearance for BOSTON EO RIGID GAS PERMEABLE CONTACT L..., manufactured by Polymer Technology Div. Wilmington Partners, L.P.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K980741 · Polymer Technology Div. Wilmington Partners, L.P. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
74d
Days
Class 2
Risk

K980741 is an FDA 510(k) clearance for the BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B). Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Polymer Technology Div. Wilmington Partners, L.P. (Rochester, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 74 days - a notably fast clearance 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: 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 Polymer Technology Div. Wilmington Partners, L.P. devices

FDA 510(k) Submission Details - K980741

510(k) Number K980741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1998
Decision Date May 11, 1998
Days to Decision 74 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
36d faster than avg
Panel avg: 110d · This submission: 74d
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 73
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K980741.
OXYCON LENS
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K980197 · Specialty Ultravision, Inc. · Aug 1998
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K972443 · Menicon U.S.A., Inc. · Aug 1997
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL
K963512 · Benz Research and Development Corp. · Jul 1997