Iosert Lens Implant Instrument
FDA 510(k) K854197 · Chiron Vision Corp.
510(k) numberK854197
Submission
- Device name
- Iosert Lens Implant Instrument
- Applicant
- Chiron Vision Corp.
Irvine, CA, US - Received
- October 15, 1985
- Decision date
- January 22, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K970727 | Mport Foldable Lens Placement SystemMSS · Traditional | 12/17/1997SE |
| K972808 | Hansatome MicrokeratomeHNO · Traditional | 10/24/1997SE |
| K960414 | Synergist Power PackHQC · Traditional | 04/24/1996SE |
| K944993 | Iolab.Site CD Phacoemulsification ModuleHQC · Traditional | 10/12/1995SE |
| K944995 | Iolab/Site Peristaltic ModuleHQC · Traditional | 10/05/1995SE |
| K951292 | Passport Foldable Lens Placement SystemKYB · Traditional | 06/02/1995SE |
| K944994 | Iolab/Site Disposable Diaphragm CassetteHQC · Traditional | 03/14/1995SE |
| K941550 | Automatic Corneal Shaper Surgical InstrumentHNO · Traditional | 11/22/1994SE |
| K935233 | Iolab Lacrimal Duct CatheterOKS · Traditional | 09/15/1994SE |
| K925606 | Optical Zone/Hexagonal/Astigmatism/Radial MarkersHMR · Traditional | 08/29/1994SE |
Questions and answers
When was Iosert Lens Implant Instrument cleared by the FDA?
Iosert Lens Implant Instrument (K854197) received a 510(k) decision of Substantially Equivalent on January 22, 1986, 99 days after the submission was received.
What is the product code of K854197?
The FDA product code is KYB – Lens, Guide, Intraocular, a Class I (low risk) device regulated under 21 CFR 886.4300.