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510(k) K853580

MEDILAS 2 by Endo Lase, Inc. — Product Code LKW

K853580 is an FDA 510(k) premarket notification submitted by Endo Lase, Inc. for the device "MEDILAS 2". The FDA issued a decision of Substantially Equivalent on February 13, 1986. The device falls under product code LKW (Laser, Neurosurgical), a Class III device. Endo Lase, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1986
Date Received
August 26, 1985
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 Endo Lase, Inc.

  • K853900 — ENDO-LASE CD40 FOR NEUROSURGERY (June 18, 1986)
  • K853878 — ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY (May 2, 1986)
  • K855093 — MEDILAS 2 ND:YAG LASER SURGERY SYSTEM (February 21, 1986)
  • K853903 — ENDO-LASE CD40 CO2 FOR GYNECOLOGY (February 21, 1986)
  • K853876 — ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY (February 21, 1986)
  • K853877 — ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY (February 19, 1986)
  • K853901 — ENDO-LASE CD 40 FOR DERMATOLOGY (February 19, 1986)
  • K860152 — MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY (February 5, 1986)
  • K853902 — ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY (January 9, 1986)
  • K853875 — ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY (January 9, 1986)

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)
  • K844440 — MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL (May 9, 1985)

FDA data resources