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510(k) K880592

LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE by Laser Peripherals, LLC — Product Code LLO

K880592 is an FDA 510(k) premarket notification submitted by Laser Peripherals, LLC for the device "LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE". The FDA issued a decision of Substantially Equivalent on April 25, 1988. The device falls under product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery), a Class II device regulated under 21 CFR 874.4500. Laser Peripherals, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1988
Date Received
February 11, 1988
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 Laser Peripherals, LLC

  • K170366 — Laser Peripherals, LLC Family of Bare Laser Fibers (June 8, 2017)
  • K030959 — BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-10 (April 25, 2003)
  • K011207 — LASER PERIPHERALS REUSABLE HOLMIUM FIBER (July 24, 2001)
  • K992083 — SCATTERFREE LATERAL EMITTING FIBER (July 12, 1999)
  • K974229 — LS-905 FIBERCHOICE ADAPTER SYSTEM (February 10, 1998)
  • K972272 — LASER PERIPHERALS HOLMIUM BARE FIBERS (July 29, 1997)
  • K961516 — LASER PERIPHERALS INC. BARE FIBER (June 27, 1996)
  • K961079 — LASER PERIPHERALS INC. SCATTERFREE FIBER (May 22, 1996)
  • K901786 — LASEGUIDE CAT # CLF-600D & CLF-1000D (June 27, 1990)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)

Other clearances for product code LLO

  • K884815 — SLT CLMD CONTACT LASER (December 22, 1988)
  • K881499 — SURGILASE YAG 100 FOR GYNECOLOGY USE (April 29, 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)
  • K862698 — 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (August 5, 1986)

FDA data resources