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510(k) K874254

ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS by Minnesota Laser Corp. — Product Code LLO

K874254 is an FDA 510(k) premarket notification submitted by Minnesota Laser Corp. for the device "ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS". The FDA issued a decision of Substantially Equivalent on March 4, 1988. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Minnesota Laser Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1988
Date Received
October 20, 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 Minnesota Laser Corp.

  • K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (July 12, 1988)
  • K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (July 12, 1988)
  • K854473 — PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC (June 20, 1986)
  • K854468 — PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC (June 20, 1986)
  • K854471 — PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T (February 13, 1986)
  • K854472 — PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG (February 11, 1986)
  • K854469 — PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG (February 11, 1986)
  • K854470 — PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI (February 7, 1986)
  • K852694 — PORTALASE 200 CARBON SURGICAL LASER SYSTEM (September 30, 1985)
  • K852696 — FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY (September 19, 1985)

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)
  • 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)
  • K862698 — 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (August 5, 1986)

FDA data resources