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510(k) K844869

FIBERLASE 100 MEDICAL LASER SYSTEM by Laser Media — Product Code LLO

K844869 is an FDA 510(k) premarket notification submitted by Laser Media for the device "FIBERLASE 100 MEDICAL LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 14, 1985. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Laser Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1985
Date Received
December 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neodymium:Yag, Pulmonary Surgery
Device Class
Class II
Regulation Number
874.4500
Review Panel
AN
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 LLO

  • K884815 — SLT CLMD CONTACT LASER (December 22, 1988)
  • K881499 — SURGILASE YAG 100 FOR GYNECOLOGY USE (April 29, 1988)
  • K880592 — LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE (April 25, 1988)
  • K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (March 24, 1988)
  • K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (March 4, 1988)
  • K875104 — SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (February 2, 1988)
  • K871876 — MODEL 5050 SURGILASER FOR PULMONARY USE (January 22, 1988)
  • K872351 — FIBERLASE II ND:YAG LASER FOR PULMONARY USE (December 11, 1987)
  • K870505 — OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL (August 7, 1987)
  • K871511 — SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (July 21, 1987)

FDA data resources