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510(k) K142567

RETeval Visual Electrodiagnostic Device by Lkc Technologies, Inc. — Product Code GWE

K142567 is an FDA 510(k) premarket notification submitted by Lkc Technologies, Inc. for the device "RETeval Visual Electrodiagnostic Device". The FDA issued a decision of Substantially Equivalent on May 19, 2015. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Lkc Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2015
Date Received
September 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

Other clearances by Lkc Technologies, Inc.

  • K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1] (October 25, 1991)
  • 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 GWE

  • K221471 — E3 and Profile (November 22, 2022)
  • K212936 — Vision Monitor- MonCvONE (November 21, 2022)
  • K211974 — LED PHOTIC System (September 23, 2021)
  • K211643 — Vision Monitor - MonpackONE (July 26, 2021)
  • K200705 — Nurochek System (April 23, 2020)
  • K173936 — Natus Photic Stimulator (June 15, 2018)
  • K113785 — ADHERENT VISUAL STIMULATOR GOGGLES (June 6, 2012)
  • K120104 — VISIONSEARCH 1 (May 21, 2012)
  • K101763 — DIOPSYS NOVA VEP VISION TESTING SYSTEM (May 9, 2011)
  • K101691 — LIFELINES PHOTIC STIMULATOR (August 10, 2010)

FDA data resources