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510(k) K862005

LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER by Laserscope — Product Code EWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1986
Date Received
May 27, 1986
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 Laserscope

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  • K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES (March 30, 2004)
  • K024206 — AURA ISURGICAL LASER SYSTEM & ACCESSORIES (November 17, 2003)
  • K020021 — LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) (July 2, 2002)
  • K010834 — LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES (May 21, 2001)
  • K010284 — LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (May 1, 2001)
  • K003765 — LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (March 6, 2001)
  • K003147 — LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) (December 15, 2000)
  • K990718 — ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) (March 8, 2000)

Other clearances for product code EWG

  • K924652 — BENSON CCA100 (April 9, 1993)
  • K870587 — LASERMATIC SURGILASER MODEL 5050 (August 10, 1988)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K880428 — ILLUMINA 25 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)
  • K862865 — MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE (January 9, 1987)
  • K862866 — MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (January 9, 1987)