Submission Details
| 510(k) Number | K173365 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Bausch + Lomb Boston Scleral Lens Case
Nov 2017
Decision
22d
Days
Class 2
Risk
About This 510(k) Submission
K173365 is an FDA 510(k) clearance for the Bausch + Lomb Boston Scleral Lens Case, a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on November 17, 2017, 22 days after receiving the submission on October 26, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LRX — Case, Contact Lens |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
Similar Devices — LRX Case, Contact Lens
All 81
K252175 · Fourth Axis, LLC
· Feb 2026
K250495 · Avizor S.A.
· Aug 2025
K240095 · Shanghai Care US Medical Product Co., Ltd.
· Oct 2024
K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
· Aug 2023
K173538 · Alcon Laboratories, Inc.
· Dec 2017
K172925 · P L Overseas Limited
· Nov 2017
More from Bausch & Lomb, Incorporated
View all
K242389
· MSS · Oct 2024
K230954
· LPL · Nov 2023
K220613
· LPL · Mar 2023
K222541
· LPN · Dec 2022
K211786
· LYX · Dec 2021