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510(k) K870587

LASERMATIC SURGILASER MODEL 5050 by Lasermatic OY — Product Code EWG

K870587 is an FDA 510(k) premarket notification submitted by Lasermatic OY for the device "LASERMATIC SURGILASER MODEL 5050". The FDA issued a decision of SN on August 10, 1988. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Lasermatic OY has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 10, 1988
Date Received
February 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ent Microsurgical Carbon-Dioxide
Device Class
Class II
Regulation Number
874.4500
Review Panel
EN
Submission Type

Other clearances by Lasermatic OY

  • 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)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)
  • K871876 — MODEL 5050 SURGILASER FOR PULMONARY USE (January 22, 1988)
  • K871933 — MODEL 5050 SURGILASER FOR NEUROSURGERY USE (January 22, 1988)

Other clearances for product code EWG

  • K924652 — BENSON CCA100 (April 9, 1993)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K872710 — MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT (September 24, 1987)
  • K870840 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH (June 12, 1987)
  • K864975 — LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) (February 25, 1987)
  • K862866 — MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (January 9, 1987)
  • K862865 — MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE (January 9, 1987)
  • K862150 — MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) (September 4, 1986)

FDA data resources