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510(k) K860063

ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM by Laser Media — Product Code LNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1986
Date Received
January 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type

Other clearances by Laser Media

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  • K872350 — FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE (August 10, 1987)
  • K872031 — UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM (August 4, 1987)
  • K863428 — SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG (December 3, 1986)
  • K863583 — CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER (November 24, 1986)
  • K862444 — FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA (September 25, 1986)
  • K855197 — FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM (January 21, 1986)
  • K852798 — FIBERLASE 100 MEDICAL LASER SYSTEM (July 29, 1985)
  • K850509 — ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM (April 8, 1985)

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  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (April 14, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
  • K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (April 13, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)