Monarch III Iol Delivery System; Monarch III P Catridge; Monarch III Handpiece (H4)
FDA 510(k) K101774 · Alcon Manufacturing, Ltd.
510(k) numberK101774
Submission
- Device name
- Monarch III Iol Delivery System; Monarch III P Catridge; Monarch III Handpiece (H4)
- Applicant
- Alcon Manufacturing, Ltd.
Fort Worth, TX, US - Received
- June 24, 2010
- Decision date
- October 13, 2011
- 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
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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 |
| 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 |
|---|---|---|
| K120912 | Infiniti(R) Vision SystemHQC · Traditional | 06/15/2012SE |
| K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceHQC · Traditional | 11/21/2011SE |
| K101285 | Constellation Vision SystemHQC · Traditional | 11/12/2010SE |
| K093210 | Aqualase Capsule Wash TipHQC · Traditional | 03/04/2010SE |
| K063155 | Monarch III Iol Delivery SystemKYB · Traditional | 03/27/2007SE |
Questions and answers
When was Monarch III Iol Delivery System; Monarch III P Catridge; Monarch III Handpiece (H4) cleared by the FDA?
Monarch III Iol Delivery System; Monarch III P Catridge; Monarch III Handpiece (H4) (K101774) received a 510(k) decision of Substantially Equivalent on October 13, 2011, 476 days after the submission was received.
What is the product code of K101774?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.