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510(k) K860496

MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY by Xanar, Inc. — Product Code LNK

K860496 is an FDA 510(k) premarket notification submitted by Xanar, Inc. for the device "MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code LNK (Laser For Gastro-Urology Use), a Class II device regulated under 21 CFR 878.4810. Xanar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
February 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type

Other clearances by Xanar, Inc.

  • K861688 — XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 (October 3, 1986)
  • K852436 — AMBULASE (April 18, 1986)
  • K853620 — MODEL XA-50 - CO2 SURGICAL LASER (January 24, 1986)
  • K850804 — CO 2 SURGICAL LASER SYSTEM NA-30 (August 15, 1985)
  • K850805 — CO 2 SURGICAL LASER SYSTEM MODEL NA-40 (August 15, 1985)
  • K850818 — CO 2 SURGICAL LASER SYSTEM NA-120 (August 15, 1985)
  • K844087 — XANAR MODEL XSE-300 SMOKE EVACULATER (February 27, 1985)
  • K841860 — CO2 SURGICAL LASER SYSTEM XML-10 (November 8, 1984)
  • K833325 — AMBULASE XAM-15 XANAR SURG. LASER (January 26, 1984)
  • K837224 — UNKNOWN (May 2, 1983)

Other clearances for product code LNK

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K901723 — MDL-2000 LASERTRIPTER (July 13, 1990)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
  • K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (April 14, 1988)
  • K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (April 13, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)

FDA data resources