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510(k) K830557

ERG-JET ELECTRODE by Universo S.A. — Product Code HLZ

K830557 is an FDA 510(k) premarket notification submitted by Universo S.A. for the device "ERG-JET ELECTRODE". The FDA issued a decision of Substantially Equivalent on March 31, 1983. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1983
Date Received
February 23, 1983
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 for product code HLZ

  • K253586 — RM Electrode (RMH 25-01) (April 1, 2026)
  • K232273 — RM Electrode (RMH 23-01) (December 7, 2023)
  • K961805 — TOMEY DTL ELECTRODE (May 9, 1997)
  • K926540 — SOPHER AND BIERER OVUM FORCEPS (February 25, 1994)
  • K913239 — GOLDLENS(TM) (January 31, 1992)
  • K844409 — DTL ELECTRODE (February 14, 1985)
  • 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