CLAREON MONARCH IV IOL Delivery System
FDA 510(k) K212039 · Alcon Laboratories, Inc.
510(k) numberK212039
Submission
- Device name
- CLAREON MONARCH IV IOL Delivery System
- Applicant
- Alcon Laboratories, Inc.
Fort Worth, TX, US - Received
- June 30, 2021
- Decision date
- August 23, 2021
- 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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| K231838 | RxSight® Insertion Device (63002)MSS · Traditional | Rxsight, Inc. | 08/15/2023SE |
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| K200057 | bioli lOL Delivery SystemMSS · Traditional | Ast Products, Inc. | 06/04/2020SE |
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| 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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| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…LPL · Traditional | 11/16/2023SE |
| K230785 | Precision1, Precision1 for AstigmatismLPL · Special | 04/20/2023SE |
Questions and answers
When was CLAREON MONARCH IV IOL Delivery System cleared by the FDA?
CLAREON MONARCH IV IOL Delivery System (K212039) received a 510(k) decision of Substantially Equivalent on August 23, 2021, 54 days after the submission was received.
What is the product code of K212039?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.