EyeGility Inserter for Preloaded enVista IOLs
FDA 510(k) K242389 · Bausch & Lomb, Incorporated
510(k) numberK242389
Submission
- Device name
- EyeGility Inserter for Preloaded enVista IOLs
- Applicant
- Bausch & Lomb, Incorporated
Rochester, NY, US - Received
- August 12, 2024
- Decision date
- October 10, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSS – Folders And Injectors, Intraocular Lens (Iol)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Specialty
- Ophthalmic
Other 510(k)s with product code MSS
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|---|---|---|---|
| K261174 | RxSight® Insertion DeviceMSS · Special | Rxsight, Inc. | 06/10/2026SE |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590)MSS · Traditional | Medicel AG | 09/16/2025SE |
| K231106 | Accuject Refra Injector AR2900MSS · Traditional | Medicel AG | 09/19/2023SE |
| K231838 | RxSight® Insertion Device (63002)MSS · Traditional | Rxsight, Inc. | 08/15/2023SE |
| K231466 | RxSight Insertion DeviceMSS · Special | Rxsight, Inc. | 06/12/2023SE |
| K212039 | CLAREON MONARCH IV IOL Delivery SystemMSS · Traditional | Alcon Laboratories, Inc. | 08/23/2021SE |
| K200057 | bioli lOL Delivery SystemMSS · Traditional | Ast Products, Inc. | 06/04/2020SE |
| K192926 | RxSight Insertion DeviceMSS · Traditional | Rxsight, Inc. | 01/17/2020SE |
| K192005 | Bausch + Lomb PreVue Inserter for enVista PreloadedMSS · Special | Bausch & Lomb, Inc. | 10/04/2019SE |
| K191949 | UNFOLDER Vitan InserterMSS · Abbreviated | Johnson & Johnson Surgical Vision, Inc. | 09/13/2019SE |
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| K200416 | Boston One Step Liquid Enzymatic CleanerMRC · Traditional | 09/23/2020SE |
| K192005 | Bausch + Lomb PreVue Inserter for enVista PreloadedMSS · Special | 10/04/2019SE |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…HQD · Traditional | 02/12/2019SE |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact LensLPL · Traditional | 11/30/2018SE |
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Questions and answers
When was EyeGility Inserter for Preloaded enVista IOLs cleared by the FDA?
EyeGility Inserter for Preloaded enVista IOLs (K242389) received a 510(k) decision of Substantially Equivalent on October 10, 2024, 59 days after the submission was received.
What is the product code of K242389?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.