HMR — Marker, Ocular Class I
FDA product code HMR covers "Marker, Ocular", a Class I medical device regulated under 21 CFR 886.4570. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HMR
- Device Class
- Class I
- Regulation Number
- 886.4570
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K053475 | refractec | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | March 3, 2006 |
| K925606 | chiron vision | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | August 29, 1994 |
| K872747 | innomed | LASER CENTERING DEVICE | September 4, 1987 |
| K863663 | myocure | OPHTHALMIC SURGICAL OCULAR MARKERS | October 20, 1986 |
| K861535 | coopervision | OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU | May 14, 1986 |