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510(k) K894765

SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 by Laser Industries , Ltd. — Product Code FYD

K894765 is an FDA 510(k) premarket notification submitted by Laser Industries , Ltd. for the device "SHARPLAN SMOKE EVACUATION UNIT, MODEL 100". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Laser Industries , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
July 26, 1989
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 Industries , Ltd.

  • K933362 — SHARPLAN CO2 SURGICAL LASER (April 7, 1994)
  • K850633 — SHARPLAN MODEL 1060 CO/2 SURGICAL LASER (August 7, 1985)
  • K850628 — SHARPLAN 1040 CO/2 SURGICAL LASER (August 7, 1985)
  • K842997 — LASER RECTOSCOPE SET 784 (August 27, 1984)
  • K832550 — SHARPLAN #734 LASER SURGICAL UNIT (April 25, 1984)
  • K832551 — SHARPLAN #745 LASER SURG. UNIT (April 23, 1984)
  • K832316 — OPHTHALMIC ARGON LASER #700A (January 30, 1984)
  • K837573 — SHARPLAN LASER POSITIONING SYSTEM (June 28, 1983)
  • K837342 — SHARPLAN 721 CO2 SURGICAL LASER (May 18, 1983)
  • K837081 — MICROSCAN 771 MANIPULATOR (March 9, 1983)

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