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510(k) K852695

FOR USE IN EAR; NOSE & THROAT MICROSURGERY by Minnesota Laser Corp. — Product Code EWG

K852695 is an FDA 510(k) premarket notification submitted by Minnesota Laser Corp. for the device "FOR USE IN EAR; NOSE & THROAT MICROSURGERY". The FDA issued a decision of Substantially Equivalent on August 30, 1985. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Minnesota Laser Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1985
Date Received
June 26, 1985
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 Minnesota Laser Corp.

  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (March 4, 1988)
  • K854468 — PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC (June 20, 1986)
  • K854473 — PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC (June 20, 1986)
  • K854471 — PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T (February 13, 1986)
  • K854472 — PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG (February 11, 1986)
  • K854469 — PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG (February 11, 1986)
  • K854470 — PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI (February 7, 1986)
  • K852694 — PORTALASE 200 CARBON SURGICAL LASER SYSTEM (September 30, 1985)

Other clearances for product code EWG

  • K924652 — BENSON CCA100 (April 9, 1993)
  • K870587 — LASERMATIC SURGILASER MODEL 5050 (August 10, 1988)
  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K880429 — ILLUMINA 55 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)

FDA data resources