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510(k) K893171

VISTA STREAK RETINOSCOPE (AC-POWERED) by Keeler Instruments, Inc. — Product Code HKL

K893171 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "VISTA STREAK RETINOSCOPE (AC-POWERED)". The FDA issued a decision of Substantially Equivalent on September 21, 1989. The device falls under product code HKL (Retinoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1780. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1989
Date Received
April 25, 1989
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 Keeler Instruments, Inc.

  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)
  • K100500 — PSL CLASSIC SLIT LAMP (March 9, 2010)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE (May 23, 2006)
  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)

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)
  • K812764 — KOI BLUE FIELD ENTOPTOSCOPE (December 2, 1981)
  • K800238 — MOIRE FRINGE VISOMETER AFTER LOTMAR (March 10, 1980)

FDA data resources