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510(k) K904753

DIOLASE by Scanditronix, Inc. — Product Code IWE

K904753 is an FDA 510(k) premarket notification submitted by Scanditronix, Inc. for the device "DIOLASE". The FDA issued a decision of Substantially Equivalent on November 9, 1990. The device falls under product code IWE (Monitor, Patient Position, Light-Beam), a Class I device regulated under 21 CFR 892.5780. Scanditronix, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1990
Date Received
October 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type

Other clearances by Scanditronix, Inc.

  • K934303 — RFA A-300 (August 9, 1994)
  • K942092 — DPD-3 (July 29, 1994)
  • K925133 — DPD-510 THERAPEUTIC RADIATION DOSIMETER (January 4, 1993)
  • K914926 — SCANDIPLAN - VERSION 338 (May 28, 1992)
  • K900434 — MM-22 MICROTRON, MM50 MICROTRON (October 23, 1990)
  • K843366 — SUPERPETT (November 21, 1984)

Other clearances for product code IWE

  • K152303 — CT Sim Laser System (September 11, 2015)
  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K954414 — CENTRALITE BACKPOINTER (October 23, 1995)
  • K950293 — TEC-2110 GREEN LASER MODEL MT-HNG (August 18, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K951601 — MED-TEC STRING RETICLE TRAY (May 11, 1995)
  • K943802 — HP BACK POINTER SYSTEM (December 7, 1994)
  • K943381 — LASER ALIGNMENT TOOL (August 9, 1994)
  • K941169 — TEC 2101 (MODEL MT-HPLGD) (July 18, 1994)

FDA data resources