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510(k) K862444

FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA by Laser Media — Product Code HHR

K862444 is an FDA 510(k) premarket notification submitted by Laser Media for the device "FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Laser Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
June 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
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)
  • 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)
  • K850509 — ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM (April 8, 1985)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)

FDA data resources