Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Crystalsert Lens Delivery System

K-Number: K173480 · 2017-12-11

ApplicantBausch & Lomb, Inc.
Decision Date2017-12-11
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Crystalsert Lens Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2017-12-11 under 510(k) number K173480. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Crystalsert Lens Delivery System?

Crystalsert Lens Delivery System is a medical device that received FDA 510(k) clearance on 2017-12-11. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K173480.

When did Crystalsert Lens Delivery System receive FDA 510(k) clearance?

Crystalsert Lens Delivery System received FDA 510(k) clearance on 2017-12-11, under 510(k) number K173480.

Who is the listed applicant for Crystalsert Lens Delivery System?

The FDA 510(k) record lists Bausch & Lomb, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Crystalsert Lens Delivery System?

The FDA product code for Crystalsert Lens Delivery System is MSS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETEDNCT05129488Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact LensesCOMPLETEDNCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETEDNCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETEDNCT06333015Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract ExtractionCOMPLETEDNCT06479148Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) LensTERMINATED

Other records listing Bausch & Lomb, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240005Lens, multifocal intraocularPMA P910056intraocular lensPMA P910071Fluid, intraocularPMA P860022Lens, contact (rigid gas permeable), extended wearPMA P010062Lens, contact, orthokeratology, overnightPMA N16895Lenses, soft contact, extended wear

View all 38 devices →

Related Devices (Code: MSS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑