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510(k) K833325

AMBULASE XAM-15 XANAR SURG. LASER by Xanar, Inc.

K833325 is an FDA 510(k) premarket notification submitted by Xanar, Inc. for the device "AMBULASE XAM-15 XANAR SURG. LASER". The FDA issued a decision of Substantially Equivalent on January 26, 1984. Xanar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1984
Date Received
September 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K850805 — CO 2 SURGICAL LASER SYSTEM MODEL NA-40 (August 15, 1985)
  • K850818 — CO 2 SURGICAL LASER SYSTEM NA-120 (August 15, 1985)
  • K850804 — CO 2 SURGICAL LASER SYSTEM NA-30 (August 15, 1985)
  • K844087 — XANAR MODEL XSE-300 SMOKE EVACULATER (February 27, 1985)
  • K841860 — CO2 SURGICAL LASER SYSTEM XML-10 (November 8, 1984)
  • K837224 — UNKNOWN (May 2, 1983)

FDA data resources