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510(k) K842810

INFRARED COAGULATOR by Endo Lase, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1984
Date Received
July 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
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)
  • K853876 — ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY (February 21, 1986)
  • K855093 — MEDILAS 2 ND:YAG LASER SURGERY SYSTEM (February 21, 1986)
  • K853903 — ENDO-LASE CD40 CO2 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)
  • K853580 — MEDILAS 2 (February 13, 1986)
  • K860152 — MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY (February 5, 1986)
  • K853902 — ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY (January 9, 1986)

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