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510(k) K961805

TOMEY DTL ELECTRODE by Tomey Corporation USA — Product Code HLZ

K961805 is an FDA 510(k) premarket notification submitted by Tomey Corporation USA for the device "TOMEY DTL ELECTRODE". The FDA issued a decision of Substantially Equivalent on May 9, 1997. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Tomey Corporation USA has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
May 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Corneal
Device Class
Class II
Regulation Number
886.1220
Review Panel
OP
Submission Type

Other clearances by Tomey Corporation USA

  • K971953 — CONFOSCAN (August 14, 1997)
  • K971685 — IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM (June 24, 1997)
  • K932571 — TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 (August 31, 1995)
  • K945959 — VIDEO VISION ANALYZER (VIVA), VRB 100 (March 1, 1995)
  • K944910 — TOMEY EM-1000 SPECULAR MICROSCOPE (November 22, 1994)
  • K924760 — TOMEY PROTON TONOMETER (April 5, 1993)
  • K921815 — TOMEY PE-300 PORTABLE ERG (July 15, 1992)
  • K912112 — PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (June 17, 1991)

Other clearances for product code HLZ

  • K253586 — RM Electrode (RMH 25-01) (April 1, 2026)
  • K232273 — RM Electrode (RMH 23-01) (December 7, 2023)
  • K926540 — SOPHER AND BIERER OVUM FORCEPS (February 25, 1994)
  • K913239 — GOLDLENS(TM) (January 31, 1992)
  • K844409 — DTL ELECTRODE (February 14, 1985)
  • K830557 — ERG-JET ELECTRODE (March 31, 1983)
  • K820254 — GOLD FOIL ERG ELECTRODES (April 9, 1982)
  • K813399 — ERG-JET ELECTRODE (January 22, 1982)
  • K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)
  • K760199 — ELECTRORETINOGRAPH (August 4, 1976)

FDA data resources