Tomey DTL Electrode
FDA 510(k) K961805 · Tomey Corporation USA
510(k) numberK961805
Submission
- Device name
- Tomey DTL Electrode
- Applicant
- Tomey Corporation USA
Cambridge, MA, US - Received
- May 10, 1996
- Decision date
- May 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLZ – Electrode, Corneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1220
- Specialty
- Ophthalmic
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| K232273 | RM Electrode (RMH 23-01)HLZ · Traditional | Retmap, Inc. | 12/07/2023SE |
| K926540 | Sopher and Bierer Ovum ForcepsHLZ · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K913239 | Goldlens(Tm)HLZ · Traditional | Doran Instruments, Inc. | 01/31/1992SE |
| K844409 | DTL ElectrodeHLZ · Traditional | Sauquoit Industries, Inc. | 02/14/1985SE |
| K830557 | Erg-Jet ElectrodeHLZ · Traditional | Universo S.A. | 03/31/1983SE |
| K820254 | Gold Foil Erg ElectrodesHLZ · Traditional | Cadwell Laboratories, Inc. | 04/09/1982SE |
| K813399 | Erg-Jet ElectrodeHLZ · Traditional | Nicolet Biomedical Instruments | 01/22/1982SE |
| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | Life-Tech Instruments, Inc. | 11/15/1978SE |
| K760199 | ElectroretinographHLZ · Traditional | Lkc Technologies, Inc. | 08/04/1976SE |
More from Lkc Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971953 | ConfoscanHJO · Traditional | 08/14/1997SE |
| K971685 | Imagescape Digital Retinal Image SystemHKI · Traditional | 06/24/1997SE |
| K932571 | Tomey PE-400 Portable Erg & Vep with Optional PS-4GWE · Traditional | 08/31/1995SE |
| K945959 | Video Vision Analyzer (Viva), VRB 100HKO · Traditional | 03/01/1995SE |
| K944910 | Tomey EM-1000 Specular MicroscopeHJO · Traditional | 11/22/1994SE |
| K924760 | Tomey Proton TonometerHKY · Traditional | 04/05/1993SE |
| K921815 | Tomey PE-300 Portable ErgHLT · Traditional | 07/15/1992SE |
| K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480LQJ · Traditional | 06/17/1991SE |
Questions and answers
When was Tomey DTL Electrode cleared by the FDA?
Tomey DTL Electrode (K961805) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 364 days after the submission was received.
What is the product code of K961805?
The FDA product code is HLZ – Electrode, Corneal, a Class II (moderate risk) device regulated under 21 CFR 886.1220.