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510(k) K828194

LASER LAPAROSCOPE by Laser Industries , Ltd.

K828194 is an FDA 510(k) premarket notification submitted by Laser Industries , Ltd. for the device "LASER LAPAROSCOPE". The FDA issued a decision of Substantially Equivalent on October 5, 1982. Laser Industries , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1982
Date Received
September 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Laser Industries , Ltd.

  • K933362 — SHARPLAN CO2 SURGICAL LASER (April 7, 1994)
  • K894765 — SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 (September 28, 1989)
  • K850628 — SHARPLAN 1040 CO/2 SURGICAL LASER (August 7, 1985)
  • K850633 — SHARPLAN MODEL 1060 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)

FDA data resources