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510(k) K873990

IRAS EDS INTERFEROMETRIC STIMULATOR by Randwal Instrument Co., Inc. — Product Code HLX

K873990 is an FDA 510(k) premarket notification submitted by Randwal Instrument Co., Inc. for the device "IRAS EDS INTERFEROMETRIC STIMULATOR". The FDA issued a decision of Substantially Equivalent on February 5, 1988. The device falls under product code HLX (Photostimulator, Ac-Powered), a Class II device regulated under 21 CFR 886.1630. Randwal Instrument Co., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1988
Date Received
October 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photostimulator, Ac-Powered
Device Class
Class II
Regulation Number
886.1630
Review Panel
OP
Submission Type

Other clearances by Randwal Instrument Co., Inc.

  • K873987 — IRAS GLARE TESTER (November 24, 1987)
  • K864012 — IRAS PERIMETER (December 12, 1986)
  • K853556 — LASER IRAS (November 1, 1985)
  • K842567 — PORTABLE ACUIOMETER (August 15, 1984)
  • K827577 — VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER (January 24, 1983)

Other clearances for product code HLX

  • K003442 — MODIFICATION TO EDI VERIS SYSTEM (May 4, 2001)
  • K983983 — EDI VERIS SYSTEM (February 3, 1999)
  • K925741 — CLARUS ENDOSCOPIC HOOK KNIFE (August 24, 1993)
  • K914393 — RETINA TESTER (March 2, 1992)
  • K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1] (October 25, 1991)
  • K853812 — PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (November 1, 1985)
  • K833446 — DOWNING SPECTRAL ILLUMINATOR (March 12, 1984)
  • K832762 — MILLER/NADLER GLARE TESTER (September 29, 1983)
  • K831231 — LED GOGGLES (May 16, 1983)
  • K830770 — CONTRAST SENSITIVITY EQUIPMENT (April 28, 1983)

FDA data resources