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510(k) K853556

LASER IRAS by Randwal Instrument Co., Inc. — Product Code HPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1985
Date Received
August 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Visual Field, Laser
Device Class
Class II
Regulation Number
886.1360
Review Panel
OP
Submission Type

Other clearances by Randwal Instrument Co., Inc.

  • K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR (February 5, 1988)
  • K873987 — IRAS GLARE TESTER (November 24, 1987)
  • K864012 — IRAS PERIMETER (December 12, 1986)
  • K842567 — PORTABLE ACUIOMETER (August 15, 1984)
  • K827577 — VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER (January 24, 1983)

Other clearances for product code HPJ

  • K864012 — IRAS PERIMETER (December 12, 1986)
  • K822415 — THE OCUPLOT D (September 7, 1982)
  • K813429 — LASER PHOTOCOAGULATOR ARGON MED. LASER (January 22, 1982)
  • K781507 — RETINOMETER (November 15, 1978)