Cleared Traditional

K183167 - Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens (FDA 510(k) Clearance)

Also includes:
Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183167 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
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Feb 2019
Decision
89d
Days
Class 2
Risk

K183167 is an FDA 510(k) clearance for the Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens. 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 February 12, 2019 after a review of 89 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

Submission Details

510(k) Number K183167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2018
Decision Date February 12, 2019
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K183167.
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
K253822 · Zhuhai Fitlens Medical Technology Co., Ltd. · Mar 2026
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses
K242393 · Acuity Polymers, Inc. · Nov 2024
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
K241398 · Tianjin Mastervision Technology Co., Ltd. · Oct 2024
BostonSight® Specialty Lenses
K241571 · Boston Foundation For Sight, Inc. D/B/A Bostonsight · Aug 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K240618 · Acuity Polymers, Inc. · Apr 2024
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
K233325 · Visionary Optics, LLC · Feb 2024