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510(k) K853143

COOPER LASER SONICS CUSA MODEL 200 by Cooper Lasersonics, Inc. — Product Code LBK

K853143 is an FDA 510(k) premarket notification submitted by Cooper Lasersonics, Inc. for the device "COOPER LASER SONICS CUSA MODEL 200". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code LBK (Neurosurgical Ultrasonic Instruments), a Class U device. Cooper Lasersonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
July 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Ultrasonic Instruments
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Cooper Lasersonics, Inc.

  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K880809 — ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880807 — ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K880808 — ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (March 24, 1988)
  • K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (March 11, 1988)

Other clearances for product code LBK

  • K972612 — DISSECTRON PORTABLE UNIT (October 8, 1997)
  • K962952 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (November 29, 1996)
  • K884413 — CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (December 2, 1988)
  • K884412 — CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (December 2, 1988)
  • K883522 — AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT (September 30, 1988)
  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)

FDA data resources