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510(k) K841860

CO2 SURGICAL LASER SYSTEM XML-10 by Xanar, Inc. — Product Code EWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1984
Date Received
May 4, 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 Xanar, Inc.

  • K861688 — XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 (October 3, 1986)
  • K852436 — AMBULASE (April 18, 1986)
  • K860496 — MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY (March 14, 1986)
  • K853620 — MODEL XA-50 - CO2 SURGICAL LASER (January 24, 1986)
  • K850804 — CO 2 SURGICAL LASER SYSTEM NA-30 (August 15, 1985)
  • K850818 — CO 2 SURGICAL LASER SYSTEM NA-120 (August 15, 1985)
  • K850805 — CO 2 SURGICAL LASER SYSTEM MODEL NA-40 (August 15, 1985)
  • K844087 — XANAR MODEL XSE-300 SMOKE EVACULATER (February 27, 1985)
  • K833325 — AMBULASE XAM-15 XANAR SURG. LASER (January 26, 1984)
  • K837224 — UNKNOWN (May 2, 1983)

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  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K880429 — ILLUMINA 55 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)