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510(k) K912347

BIPURE 1000 by Laser Engineering, Inc. — Product Code FYD

K912347 is an FDA 510(k) premarket notification submitted by Laser Engineering, Inc. for the device "BIPURE 1000". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Laser Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
May 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

Other clearances by Laser Engineering, Inc.

  • K211605 — Dual Switch (September 22, 2022)
  • K141908 — DUAL SWITCH (October 22, 2014)
  • K924457 — MICROMANIPULATOR (May 7, 1993)
  • K912247 — UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY (November 13, 1991)
  • K910062 — 02-10,001 (August 16, 1991)
  • K911852 — COMPULSE CO2 SURGICAL LASER SYS. (June 7, 1991)
  • K905676 — MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH (April 22, 1991)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K881585 — MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE (June 3, 1988)
  • K881581 — MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE (June 3, 1988)

Other clearances for product code FYD

  • K240127 — PlumeSafe X5 Smoke Management System (August 5, 2024)
  • K233789 — 8Q10 Surclear Smoke Plume Evacuation System (April 10, 2024)
  • K213068 — Medline Smoke Evacuation Shroud (January 3, 2022)
  • K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System (March 25, 2021)
  • K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect (June 26, 2020)
  • K192035 — EvaQMax Smoke Evacuation System (August 29, 2019)
  • K191328 — Megadyne Foot Switch (July 26, 2019)
  • K182224 — SafeAir Smoke Evacuator compact (February 7, 2019)
  • K173108 — Smoklean (May 18, 2018)
  • K163659 — Crystal Vision (October 30, 2017)

FDA data resources