Home / 510(k) Clearances / K810699

510(k) K810699

PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM by Visidyne Corp. — Product Code HLX

K810699 is an FDA 510(k) premarket notification submitted by Visidyne Corp. for the device "PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 9, 1981. The device falls under product code HLX (Photostimulator, Ac-Powered), a Class II device regulated under 21 CFR 886.1630. Visidyne Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1981
Date Received
March 16, 1981
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 Visidyne Corp.

  • K811316 — TRISCAN, MODELS 38,40,41,43 & 45 (July 2, 1981)
  • K810700 — CHROMOPS FM-100 COLOR VISION TESTER (April 10, 1981)

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)
  • 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)

FDA data resources