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510(k) K875104

SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE by Laserguide — Product Code LLO

K875104 is an FDA 510(k) premarket notification submitted by Laserguide for the device "SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE". The FDA issued a decision of Substantially Equivalent on February 2, 1988. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Laserguide has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
December 18, 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 Laserguide

  • K880071 — SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE (March 22, 1988)
  • K873892 — SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (February 2, 1988)
  • K873664 — LIGHT-SPOT FIBEROPTIC LASER HANDPIECE (November 6, 1987)
  • K873571 — LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE (November 6, 1987)

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)
  • 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