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510(k) K914163

SCOPTOPIC SENSITIVITY TEST-1[SST-1] by Lkc Technologies, Inc. — Product Code HLX

K914163 is an FDA 510(k) premarket notification submitted by Lkc Technologies, Inc. for the device "SCOPTOPIC SENSITIVITY TEST-1[SST-1]". The FDA issued a decision of Substantially Equivalent on October 25, 1991. The device falls under product code HLX (Photostimulator, Ac-Powered), a Class II device regulated under 21 CFR 886.1630. Lkc Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1991
Date Received
September 17, 1991
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 Lkc Technologies, Inc.

  • K142567 — RETeval Visual Electrodiagnostic Device (May 19, 2015)
  • K913962 — ANOMALOSCOPE QUADRANT TEST-6 (October 23, 1991)
  • K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5] (February 5, 1988)
  • K874336 — PATTERN DISCRIMINATION PERIMETER (January 12, 1988)
  • K820414 — UNIVERSAL TESTING & ANALYSIS SYSTEMS (March 4, 1982)
  • K790109 — TELEMETRY, BIOMEDICAL (March 16, 1979)
  • K760199 — ELECTRORETINOGRAPH (August 4, 1976)

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)
  • K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR (February 5, 1988)
  • 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