Crystalsert Lens Delivery System
FDA 510(k) K173480 · Bausch & Lomb, Inc.
510(k) numberK173480
Submission
- Device name
- Crystalsert Lens Delivery System
- Applicant
- Bausch & Lomb, Inc.
St. Louis, MO, US - Received
- November 13, 2017
- Decision date
- December 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K242389 | EyeGility Inserter for Preloaded enVista IOLsMSS · Traditional | Bausch & Lomb, Incorporated | 10/10/2024SE |
| 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 |
More from Bausch & Lomb, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242389 | EyeGility Inserter for Preloaded enVista IOLsMSS · Traditional | 10/10/2024SE |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon…LPL · Traditional | 03/08/2023SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | 12/06/2022SE |
| K202932 | ABT12 multi-purpose solutionLPN · Traditional | 05/28/2021SE |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaLPL · Traditional | 05/24/2021SE |
| 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 |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…MRC · Traditional | 08/10/2018SE |
Questions and answers
When was Crystalsert Lens Delivery System cleared by the FDA?
Crystalsert Lens Delivery System (K173480) received a 510(k) decision of Substantially Equivalent on December 11, 2017, 28 days after the submission was received.
What is the product code of K173480?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.