MONARCH IOL DELIVERY SYSTEM
FDA 510(k) clearance K981571 · decided 1998-07-09
Clearance details
- K-number
- K981571
- Device name
- MONARCH IOL DELIVERY SYSTEM
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-05-04
- Decision date
- 1998-07-09
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- KYB
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MicroSTAAR Injector System Cartridges (K152357) | STAAR Surgical Company | 2015-10-30 |
| DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (K081382) | Duckworth & Kent, Ltd. | 2008-10-23 |
| DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (K072985) | Duckworth & Kent, Ltd. | 2008-06-20 |
| IOL INJECTOR SET (K070669) | Medicel AG | 2007-11-01 |
| MONARCH III IOL DELIVERY SYSTEM (K063155) | Alcon Manufacturing, Ltd. | 2007-03-27 |
| AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (K063694) | Bausch & Lomb, Inc. | 2007-03-07 |
| RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412) | Staar Surgical Co. | 2004-06-10 |
| MASTEL 1 FOLDER IMPLANTATION SYSTEM (K022723) | Mastel Precision, Inc. | 2002-12-26 |
| MONARCH II IOL DELIVERY SYSTEM (K001157) | Alcon Research, Ltd. | 2000-06-27 |
| DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (K983129) | Staar Surgical Co. | 1998-12-04 |
| MONARCH IOL DELIVERY SYSTEM (K970033) | Alcon Laboratories | 1997-04-23 |
| ACRYPAK FOLDER (K965185) | Alcon Laboratories | 1997-03-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (P840064/S091) | Alcon Laboratories | 2025-10-03 |
| VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Ophthalmic Viscosurgical Device (P840064/S090) | Alcon Laboratories | 2025-07-25 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088) | Alcon Laboratories | 2025-02-26 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086) | Alcon Laboratories | 2024-08-12 |
| PMMA Single-Piece Anterior Chamber IOL (P880087/S033) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071) | Alcon Laboratories | 2024-06-20 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S085) | Alcon Laboratories | 2024-06-17 |