Passport Foldable Lens Placement System
FDA 510(k) K951292 · Chiron Vision Corp.
510(k) numberK951292
Submission
- Device name
- Passport Foldable Lens Placement System
- Applicant
- Chiron Vision Corp.
San Lorenzo, PR, US - Received
- March 22, 1995
- Decision date
- June 2, 1995
- 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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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 |
| 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 |
| K926412 | Micron-Scope IIHMS · Traditional | 07/19/1994SE |
Questions and answers
When was Passport Foldable Lens Placement System cleared by the FDA?
Passport Foldable Lens Placement System (K951292) received a 510(k) decision of Substantially Equivalent on June 2, 1995, 72 days after the submission was received.
What is the product code of K951292?
The FDA product code is KYB – Lens, Guide, Intraocular, a Class I (low risk) device regulated under 21 CFR 886.4300.