Cleared Traditional

K173365 - Bausch + Lomb Boston Scleral Lens Case

K173365 is the FDA 510(k) clearance for Bausch + Lomb Boston Scleral Lens Case by Bausch & Lomb, Incorporated. It is a Class 2 Ophthalmic device (product code LRX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K173365 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
22d
Days
Class 2
Risk

K173365 is an FDA 510(k) clearance for the Bausch + Lomb Boston Scleral Lens Case. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on November 17, 2017 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 K173365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2017
Decision Date November 17, 2017
Days to Decision 22 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
88d faster than avg
Panel avg: 110d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LRX Case, Contact Lens

All 12
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K173365.
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095 · Shanghai Care US Medical Product Co., Ltd. · Oct 2024
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Aug 2023
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K173538 · Alcon Laboratories, Inc. · Dec 2017
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
CYBERCASES BY BAUSCH & LOMB
K013232 · Bausch & Lomb, Inc. · Nov 2001
ALCON CONTACT LENS CASE
K974281 · Alcon Laboratories · Jan 1998