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510(k) K843514

MINUTEMAN CO2 MICROSURGICAL LASER OTO by American Surgical Laser, Inc. — Product Code EWG

K843514 is an FDA 510(k) premarket notification submitted by American Surgical Laser, Inc. for the device "MINUTEMAN CO2 MICROSURGICAL LASER OTO". The FDA issued a decision of Substantially Equivalent on December 4, 1984. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. American Surgical Laser, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1984
Date Received
September 5, 1984
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 American Surgical Laser, Inc.

  • K843515 — MINUTEMAN CO2 MICROSURGICAL LASER GYN (February 4, 1985)
  • K843518 — MINUTEMAN C02 MICROSURG LASER PODIATRY (December 7, 1984)
  • K843517 — MINUTEMAN CO2 MICROSURG LASER DERMATOL- (December 7, 1984)
  • K843519 — MINUTEMAN CO2 MICROSURG LASER GEN SURG (December 7, 1984)

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