Chiron Vision Corp.
Irvine, CA, US
Chiron Vision Corp. appears in FDA device records in Irvine, CA. FDA records list 34 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 34
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 34 510(k) clearances for Chiron Vision Corp. between 1980 and 1997. The busiest year on record is 1984, with 10. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1983 | 1 |
| 1984 | 10 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1992 | 5 |
| 1994 | 5 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K970727 | MPORT FOLDABLE LENS PLACEMENT SYSTEM | MSS | Substantially Equivalent | |
| K972808 | HANSATOME MICROKERATOME | HNO | Substantially Equivalent | |
| K960414 | SYNERGIST POWER PACK | HQC | Substantially Equivalent | |
| K944993 | IOLAB.SITE CD PHACOEMULSIFICATION MODULE | HQC | Substantially Equivalent | |
| K944995 | IOLAB/SITE PERISTALTIC MODULE | HQC | Substantially Equivalent | |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | KYB | Substantially Equivalent | |
| K944994 | IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE | HQC | Substantially Equivalent | |
| K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT | HNO | Substantially Equivalent | |
| K935233 | IOLAB LACRIMAL DUCT CATHETER | OKS | Substantially Equivalent | |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | HMR | Substantially Equivalent | |
| K926412 | MICRON-SCOPE II | HMS | Substantially Equivalent | |
| K932600 | MODIFIED SITE POWER HANDPIECE II | EKX | Substantially Equivalent | |
| K924198 | MODIFIED SITE FIBER OPTIC MODULE | FCT | Substantially Equivalent | |
| K922595 | MODIFIED SITE MACROBORE PHACO NEEDLE | HQC | Substantially Equivalent | |
| K922996 | MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS | KYG | Substantially Equivalent | |
| K921607 | IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE | HQC | Substantially Equivalent | |
| K922077 | MODIFIED SITE POWER HANDPIECE | EKX | Substantially Equivalent | |
| K885164 | LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM | HQF | Substantially Equivalent | |
| K883199 | MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM | HQC | Substantially Equivalent | |
| K871245 | LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 | LQJ | Substantially Equivalent | |
| K854197 | IOSERT LENS IMPLANT INSTRUMENT | KYB | Substantially Equivalent | |
| K843276 | IOCARE CONVERTER KIT | HQC | Substantially Equivalent | |
| K844666 | SITE ULTRASONIC EMULSIFICATION MODULE OP | HQC | Substantially Equivalent | |
| K843278 | IOCARE ULTRASONIC TITANIUM TIPS | HQC | Substantially Equivalent | |
| K843277 | IOCARE PHACOEMULSIFICATION PACK | HQC | Substantially Equivalent | |
| K843275 | IOCARE IRRIGATION/ASPIRATION PACK | HQC | Substantially Equivalent | |
| K843039 | SITE ANTERIOR CAPSULOTOMER | HMX | Substantially Equivalent | |
| K842859 | MICROSCOPE MITTS SUPPORT TRAY COVER | HJO | Substantially Equivalent | |
| K842459 | SITE GILLS STYLE I/A HANDPIECE | Substantially Equivalent | ||
| K842458 | SITE SIMCOE STYLE I/A HANDPIECE | HQC | Substantially Equivalent | |
| K840965 | SITE COAXIAL I/A HANDPIECE 30 TIP | HQC | Substantially Equivalent | |
| K834340 | IOCARE IRRIGATION & ASPIRATION PACK | HQC | Substantially Equivalent | |
| K831312 | LOPEZ-HORN CARRIER | KYP | Substantially Equivalent | |
| K802651 | POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) | HQG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- HMXCannula, Ophthalmic
- KYGDevice, Irrigation, Ocular Surgery
- HMSDrum, Eye Knife Test
- MSSFolders And Injectors, Intraocular Lens (Iol)
- EKXHandpiece, Direct Drive, Ac-Powered
- FCTHeadlight, Fiberoptic Focusing
- HNOKeratome, Ac-Powered
- OKSLacrimal Stents And Intubation Sets
- HQFLaser, Ophthalmic
- KYBLens, Guide, Intraocular
- HQGLens, Spectacle, Non-Custom (Prescription)
- LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser
- HMRMarker, Ocular
- KYPSnake Bite Suction Kit
- HQCUnit, Phacofragmentation
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain