Modified Site Fiber Optic Module
FDA 510(k) K924198 · Chiron Vision Corp.
510(k) numberK924198
Submission
- Device name
- Modified Site Fiber Optic Module
- Applicant
- Chiron Vision Corp.
Horsham, PA, US - Received
- August 20, 1992
- Decision date
- November 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCT – Headlight, Fiberoptic Focusing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4335
- Specialty
- Ophthalmic
Other 510(k)s with product code FCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960767 | Light CommanderFCT · Traditional | Scieran Technologies, Inc. | 08/26/1996SE |
| K883480 | Modified Site Fiber Optic Module for Ophthal. UseFCT · Traditional | Site Microsurgical Systems, Inc. | 08/24/1988SE |
| K802770 | Fiber Optic Headlight #60-0766766FCT · Traditional | Aspen Laboratories, Inc. | 12/11/1980SE |
| K802769 | Fiber Optic Headlight #60-0765FCT · Traditional | Aspen Laboratories, Inc. | 12/11/1980SE |
| K780433 | Fiber Optic Adjustable HeadlightFCT · Traditional | Cameron-Miller, Inc. | 06/13/1978SE |
More from Cameron-Miller, Inc.
| 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 Modified Site Fiber Optic Module cleared by the FDA?
Modified Site Fiber Optic Module (K924198) received a 510(k) decision of Substantially Equivalent on November 23, 1992, 95 days after the submission was received.
What is the product code of K924198?
The FDA product code is FCT – Headlight, Fiberoptic Focusing, a Class II (moderate risk) device regulated under 21 CFR 886.4335.