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510(k) K870505

OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL by Trimedyne, Inc. — Product Code LLO

K870505 is an FDA 510(k) premarket notification submitted by Trimedyne, Inc. for the device "OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL". The FDA issued a decision of Substantially Equivalent on August 7, 1987. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Trimedyne, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1987
Date Received
February 4, 1987
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 Trimedyne, Inc.

  • K053457 — VAPORMAX II (December 21, 2005)
  • K050412 — VAPORMAX (March 14, 2005)
  • K043012 — OMNIPULSE MINI, MODEL 2120 (November 17, 2004)
  • K041660 — TRIMEDYNE HOLMIUM LASER SYSTEMS (September 8, 2004)
  • K022655 — TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH (November 7, 2002)
  • K013974 — RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A (September 23, 2002)
  • K002308 — OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, (December 20, 2000)
  • K001676 — OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, (November 2, 2000)
  • K992574 — OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MO (October 29, 1999)
  • K992230 — OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP (July 12, 1999)

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)
  • K871511 — SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (July 21, 1987)
  • K862698 — 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (August 5, 1986)

FDA data resources