Monarch II Iol Delivery System
FDA 510(k) K001157 · Alcon Research, Ltd.
510(k) numberK001157
Submission
- Device name
- Monarch II Iol Delivery System
- Applicant
- Alcon Research, Ltd.
Fort Worth, TX, US - Received
- April 10, 2000
- Decision date
- June 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYB – Lens, Guide, Intraocular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Specialty
- Ophthalmic
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| K072985 | Duckworth & Kent Ltd Injector, Model: DK7797-2KYB · Traditional | Duckworth & Kent, Ltd. | 06/20/2008SE |
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| K063155 | Monarch III Iol Delivery SystemKYB · Traditional | Alcon Manufacturing, Ltd. | 03/27/2007SE |
| K063694 | Akreos Single Use Insertion Device, Model AI-28KYB · Special | Bausch & Lomb, Inc. | 03/07/2007SE |
| K032412 | Re-Useable Microstaar Injector, Msi-SKYB · Traditional | Staar Surgical Co. | 06/10/2004SE |
| K022723 | Mastel 1 Folder Implantation SystemKYB · Traditional | Mastel Precision, Inc. | 12/26/2002SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | Staar Surgical Co. | 12/04/1998SE |
| K981571 | Monarch Iol Delivery SystemKYB · Traditional | Alcon Laboratories | 07/09/1998SE |
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Questions and answers
When was Monarch II Iol Delivery System cleared by the FDA?
Monarch II Iol Delivery System (K001157) received a 510(k) decision of Substantially Equivalent on June 27, 2000, 78 days after the submission was received.
What is the product code of K001157?
The FDA product code is KYB – Lens, Guide, Intraocular, a Class I (low risk) device regulated under 21 CFR 886.4300.