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510(k) K850509

ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM by Laser Media — Product Code LNK

K850509 is an FDA 510(k) premarket notification submitted by Laser Media for the device "ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 8, 1985. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Laser Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1985
Date Received
February 8, 1985
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

  • K872352 — FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA (December 30, 1987)
  • K872351 — FIBERLASE II ND:YAG LASER FOR PULMONARY USE (December 11, 1987)
  • 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)
  • K860063 — ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM (February 5, 1986)
  • K855197 — FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM (January 21, 1986)
  • K852798 — FIBERLASE 100 MEDICAL LASER SYSTEM (July 29, 1985)

Other clearances for product code LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K901723 — MDL-2000 LASERTRIPTER (July 13, 1990)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL 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)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)

FDA data resources