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510(k) K960040

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

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.

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  • 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)

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