FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
K Number: K925606
·
Decision Aug 29, 1994
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
4
Applicant Total
34
Review Days
662
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
- K Number
- K925606
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Vision Corp.
- Date Received
- November 5, 1992
- Decision Date
- August 29, 1994
- Product Code
- HMR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HMR | Marker, Ocular | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HMR), ordered by most recent decision date.
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
FDA 510(k)
FDA Class 1
·Ophthalmic
LASER CENTERING DEVICE
FDA 510(k)
FDA Class 1
·Ophthalmic
OPHTHALMIC SURGICAL OCULAR MARKERS
FDA 510(k)
FDA Class 1
·Ophthalmic
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Chiron Vision Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K970727 | MPORT FOLDABLE LENS PLACEMENT SYSTEM | Dec 17, 1997 | Substantially Equivalent |
| K972808 | HANSATOME MICROKERATOME | Oct 24, 1997 | Substantially Equivalent |
| K960414 | SYNERGIST POWER PACK | Apr 24, 1996 | Substantially Equivalent |
| K944993 | IOLAB.SITE CD PHACOEMULSIFICATION MODULE | Oct 12, 1995 | Substantially Equivalent |
| K944995 | IOLAB/SITE PERISTALTIC MODULE | Oct 5, 1995 | Substantially Equivalent |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Jun 2, 1995 | Substantially Equivalent |
| K944994 | IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE | Mar 14, 1995 | Substantially Equivalent |
| K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT | Nov 22, 1994 | Substantially Equivalent |
| K935233 | IOLAB LACRIMAL DUCT CATHETER | Sep 15, 1994 | Substantially Equivalent |
| K926412 | MICRON-SCOPE II | Jul 19, 1994 | Substantially Equivalent |