Mazzocco/Frenchik Folder
FDA 510(k) K860148 · Staar Surgical Co.
510(k) numberK860148
Submission
- Device name
- Mazzocco/Frenchik Folder
- Applicant
- Staar Surgical Co.
Monrovia, CA, US - Received
- January 15, 1986
- Decision date
- March 21, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYB – Lens, Guide, Intraocular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Specialty
- Ophthalmic
Other 510(k)s with product code KYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152357 | MicroSTAAR Injector System CartridgesKYB · Special | STAAR Surgical Company | 10/30/2015SE |
| K081382 | Duckworth & Kent, Ltd., Implantation System, Model DK7786KYB · Traditional | Duckworth & Kent, Ltd. | 10/23/2008SE |
| K072985 | Duckworth & Kent Ltd Injector, Model: DK7797-2KYB · Traditional | Duckworth & Kent, Ltd. | 06/20/2008SE |
| K070669 | Iol Injector SetKYB · Traditional | Medicel AG | 11/01/2007SE |
| 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 |
| K001157 | Monarch II Iol Delivery SystemKYB · Traditional | Alcon Research, Ltd. | 06/27/2000SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | Staar Surgical Co. | 12/04/1998SE |
More from Staar Surgical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K172375 | MicroSTAAR Injector System CartridgesMSS · Special | 09/06/2017SE |
| K152357 | MicroSTAAR Injector System CartridgesKYB · Special | 10/30/2015SE |
| K090161 | Epiphany Injection SystemMSS · Traditional | 06/09/2009SE |
| K073591 | Microstaar Msi Injector Foam Tip SystemMSS · Traditional | 03/13/2008SE |
| K073586 | Microstaar Indigo Injector Foam Tip SystemMSS · Traditional | 03/13/2008SE |
| K032412 | Re-Useable Microstaar Injector, Msi-SKYB · Traditional | 06/10/2004SE |
| K020734 | Surge-Free Aspiration AdapterHQC · Traditional | 05/16/2002SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | 12/04/1998SE |
| K980696 | Foam Tip InjectorMSS · Traditional | 09/11/1998SE |
| K954600 | Microstaar Injector Models Msi-Td & Msi-Pd (Modification)KYB · Traditional | 12/21/1995SE |
Questions and answers
When was Mazzocco/Frenchik Folder cleared by the FDA?
Mazzocco/Frenchik Folder (K860148) received a 510(k) decision of Substantially Equivalent on March 21, 1986, 65 days after the submission was received.
What is the product code of K860148?
The FDA product code is KYB – Lens, Guide, Intraocular, a Class I (low risk) device regulated under 21 CFR 886.4300.