Marker, Ocular
The Ocular Marker is a surgical ophthalmic instrument used to place reference marks on ocular tissues during procedures, enabling accurate alignment, measurement, or incision placement in surgeries such as LASIK, cataract extraction, or corneal transplantation. It is classified as FDA Class 1, the lowest risk level, requiring only general controls without a premarket notification. The product code is HMR, regulated under 21 CFR 886.4570, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HMR
- Device Class
- FDA class 1
- Regulation Number
- 886.4570
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K053475 | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | Mar 03, 2006 | Substantially Equivalent | Refractec, Inc. |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | Aug 29, 1994 | Substantially Equivalent | Chiron Vision Corp. |
| K872747 | LASER CENTERING DEVICE | Sep 04, 1987 | Substantially Equivalent | Innomed Corp. |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | Oct 20, 1986 | Substantially Equivalent | Myocure, Inc. |
| K861535 | OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU | May 14, 1986 | Substantially Equivalent | CooperVision, Inc. |
FEI Numbers
This FDA classification entry is associated with 97 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 97 registration numbers. Click on an entry to view related FDA registrations.