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510(k) K844440

MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL by Cooper Lasersonics, Inc. — Product Code LKW

K844440 is an FDA 510(k) premarket notification submitted by Cooper Lasersonics, Inc. for the device "MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL". The FDA issued a decision of Substantially Equivalent on May 9, 1985. The device falls under product code LKW (Laser, Neurosurgical), a Class III device. Cooper Lasersonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1985
Date Received
November 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neurosurgical
Device Class
Class III
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Cooper Lasersonics, Inc.

  • K880808 — ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU (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)
  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K880428 — ILLUMINA 25 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 LKW

  • K875042 — ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY (June 24, 1988)
  • K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (March 11, 1988)
  • K864166 — 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY (February 10, 1987)
  • K853580 — MEDILAS 2 (February 13, 1986)

FDA data resources