Cleared Traditional

K053124 - BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES

K053124 is an FDA 510(k) clearance for BOSTON ES (ENFLUFOCON A), manufactured by Bausch & Lomb, Incorporated. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K053124 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
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Jan 2006
Decision
84d
Days
Class 2
Risk

K053124 is an FDA 510(k) clearance for the BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on January 30, 2006 after a review of 84 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 Bausch & Lomb, Incorporated devices

FDA 510(k) Submission Details - K053124

510(k) Number K053124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2005
Decision Date January 30, 2006
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
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 108
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