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510(k) K960040

SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE by Sharplan Lasers, Inc. — Product Code LFL

K960040 is an FDA 510(k) premarket notification submitted by Sharplan Lasers, Inc. for the device "SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE". The FDA issued a decision of Substantially Equivalent on April 29, 1996. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Sharplan Lasers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1996
Date Received
January 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Sharplan Lasers, Inc.

  • K973354 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (December 4, 1997)
  • K972099 — SHARPLAN EPITOUCH RUBY LASER SYSTEM (August 27, 1997)
  • K971874 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (August 18, 1997)
  • K971648 — SHARPLAN ERBIUM: YAG LASER (4020) (July 23, 1997)
  • K971743 — SHARPLAN CO2 SURGICAL LASER SYSTEM (July 18, 1997)
  • K962446 — SHARPLAN RUBY LASER SYSTEM (March 7, 1997)
  • K963229 — SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS (November 5, 1996)
  • K961935 — SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER (November 1, 1996)
  • K962974 — SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) (August 21, 1996)
  • K961279 — SHARPLAN LASERS, INC. RUBY LASER SYSTEM (June 18, 1996)

Other clearances for product code LFL

  • K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System (October 8, 2025)
  • K242894 — SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultr (June 18, 2025)
  • K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (March 24, 2025)
  • K241700 — Tenex 2nd Generation System (November 18, 2024)
  • K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System (July 11, 2024)
  • K233036 — Ultrasonic Surgical System (June 18, 2024)
  • K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System (July 11, 2023)
  • K231117 — neXus Ultrasonic Surgical Aspirator System (June 23, 2023)
  • K221790 — HARMONIC 700 Shears (February 28, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)

FDA data resources