Cleared Abbreviated

K073184 - BOSTON RGP LENSES WET SHIPPED IN BOSTOM...

K073184 is the FDA 510(k) clearance for BOSTON RGP LENSES WET SHIPPED IN BOSTOM... by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code HQD) cleared through the Abbreviated 510(k) pathway after a 100-day FDA review.

K073184 · Bausch & Lomb, Inc. · Ophthalmic device
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Feb 2008
Decision
100d
Days
Class 2
Risk

K073184 is an FDA 510(k) clearance for the BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STO.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on February 21, 2008 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K073184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date February 21, 2008
Days to Decision 100 days
Submission Type Abbreviated
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
10d faster than avg
Panel avg: 110d · This submission: 100d
Pathway characteristics
Standards-based clearance path.

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 25
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K073184.
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K180988 · Acuity Polymers, Inc. · Jun 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
K180616 · Contamac, Ltd. · Apr 2018
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG
K180172 · Paragon Vision Sciences · Mar 2018
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
K071266 · Bausch & Lomb, Inc. · Aug 2007
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K071043 · Bausch & Lomb, Inc. · Aug 2007