Home / 510(k) Clearances / K855095

510(k) K855095

S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA by Surgical Laser Technologies, Inc. — Product Code LLO

K855095 is an FDA 510(k) premarket notification submitted by Surgical Laser Technologies, Inc. for the device "S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA". The FDA issued a decision of Substantially Equivalent on February 18, 1986. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Surgical Laser Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1986
Date Received
December 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neodymium:Yag, Pulmonary Surgery
Device Class
Class II
Regulation Number
874.4500
Review Panel
AN
Submission Type

Other clearances by Surgical Laser Technologies, Inc.

  • K042211 — MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS (November 8, 2004)
  • K023624 — SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-676 (January 27, 2003)
  • K011409 — SLT LASERPRO CTH HOLMIUM LASER SYSTEM (June 14, 2001)
  • K010041 — SLT DIFFUSER FIBER (March 7, 2001)
  • K984018 — HEMOSLEEVE, MODEL 4.0MM, 5.5MM (March 15, 1999)
  • K983050 — PNEUMATIC CUTTER SYSTEM (November 25, 1998)
  • K981041 — SLT BIPOLAR SHEATH (August 27, 1998)
  • K972548 — SLT CL MD CONTACT LASER SYSTEM (April 21, 1998)
  • K980156 — SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS (February 27, 1998)
  • K960821 — SLT FUMICH PROBE GUIDE (May 16, 1996)

Other clearances for product code LLO

  • K884815 — SLT CLMD CONTACT LASER (December 22, 1988)
  • K881499 — SURGILASE YAG 100 FOR GYNECOLOGY USE (April 29, 1988)
  • K880592 — LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE (April 25, 1988)
  • K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (March 24, 1988)
  • K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (March 4, 1988)
  • K875104 — SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (February 2, 1988)
  • K871876 — MODEL 5050 SURGILASER FOR PULMONARY USE (January 22, 1988)
  • K872351 — FIBERLASE II ND:YAG LASER FOR PULMONARY USE (December 11, 1987)
  • K870505 — OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL (August 7, 1987)
  • K871511 — SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (July 21, 1987)

FDA data resources