HLZ — Electrode, Corneal Class II
FDA product code HLZ covers "Electrode, Corneal", a Class II medical device regulated under 21 CFR 886.1220. Submissions are reviewed by the Ophthalmic panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HLZ
- Device Class
- Class II
- Regulation Number
- 886.1220
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253586 | retmap | RM Electrode (RMH 25-01) | April 1, 2026 |
| K232273 | retmap | RM Electrode (RMH 23-01) | December 7, 2023 |
| K961805 | tomey corporation usa | TOMEY DTL ELECTRODE | May 9, 1997 |
| K926540 | thomasville medical assoc | SOPHER AND BIERER OVUM FORCEPS | February 25, 1994 |
| K913239 | doran instruments | GOLDLENS(TM) | January 31, 1992 |
| K844409 | sauquoit industries | DTL ELECTRODE | February 14, 1985 |
| K830557 | universo | ERG-JET ELECTRODE | March 31, 1983 |
| K820254 | cadwell laboratories | GOLD FOIL ERG ELECTRODES | April 9, 1982 |
| K813399 | nicolet biomedical instruments | ERG-JET ELECTRODE | January 22, 1982 |
| K781476 | life-tech instruments | MULAR GOLD LEAF ELECTRODE MODEL 7501 | November 15, 1978 |
| K760199 | lkc technologies | ELECTRORETINOGRAPH | August 4, 1976 |