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510(k) K871876

MODEL 5050 SURGILASER FOR PULMONARY USE by Lasermatic, Inc. — Product Code LLO

K871876 is an FDA 510(k) premarket notification submitted by Lasermatic, Inc. for the device "MODEL 5050 SURGILASER FOR PULMONARY USE". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Lasermatic, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1988
Date Received
May 14, 1987
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 Lasermatic, Inc.

  • K903131 — LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM (February 19, 1991)
  • K901638 — MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 (June 27, 1990)
  • K895279 — LASERMATIC COMBOLASER MODEL 5050 (November 8, 1989)
  • K893529 — COMBOLASER MODEL 5050 (June 8, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K870587 — LASERMATIC SURGILASER MODEL 5050 (August 10, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871933 — MODEL 5050 SURGILASER FOR NEUROSURGERY USE (January 22, 1988)

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)
  • 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)
  • K862698 — 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (August 5, 1986)

FDA data resources