Home / 510(k) Clearances / K812764

510(k) K812764

KOI BLUE FIELD ENTOPTOSCOPE by Koi, Inc. — Product Code HKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1981
Date Received
October 2, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retinoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1780
Review Panel
OP
Submission Type

Other clearances by Koi, Inc.

  • K843247 — KOI PACHYMETER (April 30, 1986)
  • K830366 — DIAMOND KNIFE (March 9, 1983)
  • K812450 — KOI DIAMOND KNIFE (September 21, 1981)
  • K812097 — KOI LACREMAL HOOK & DILATOR (August 18, 1981)
  • K812010 — KOI LACRIMAL INTUBATION SYSTEM (July 28, 1981)
  • K812011 — BLADE GAUGE (July 28, 1981)

Other clearances for product code HKL

  • K001111 — PANORET, MODEL 1000A (July 7, 2000)
  • K950789 — STREAK RETINOSCOPE RX-1 (March 28, 1995)
  • K950790 — STREAK RETINOSCOPE RX-2 (March 22, 1995)
  • K893171 — VISTA STREAK RETINOSCOPE (AC-POWERED) (September 21, 1989)
  • K800238 — MOIRE FRINGE VISOMETER AFTER LOTMAR (March 10, 1980)