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510(k) K853812

PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) by Biosan Laboratories, Inc. — Product Code HLX

K853812 is an FDA 510(k) premarket notification submitted by Biosan Laboratories, Inc. for the device "PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)". The FDA issued a decision of Substantially Equivalent on November 1, 1985. The device falls under product code HLX (Photostimulator, Ac-Powered), a Class II device regulated under 21 CFR 886.1630. Biosan Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1985
Date Received
September 12, 1985
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 Biosan Laboratories, Inc.

  • K860642 — PHOTRON VISUAL FIELD ANALYZER (April 15, 1986)
  • K832763 — TOBRAMYCIN REAGENT (March 23, 1984)
  • K833193 — RADIOIMMUNOASSAY, THYROID STIMU. HORMONE (February 4, 1984)
  • K834023 — BIO-SCIENCE LABORATORIES T4 REAGENT (January 24, 1984)
  • K833318 — NORMAL GOAT SERUM (January 3, 1984)
  • K833192 — NORMAL URINE CONTROL (December 8, 1983)
  • K833320 — AMBERLITE CG50 RESIN, 100-200 MESH (December 8, 1983)
  • K833191 — ABNORMAL URINE CONTROL (December 8, 1983)
  • K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2 (November 3, 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)
  • K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR (February 5, 1988)
  • 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