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510(k) K913848

SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR by Sharplan Lasers, Inc. — Product Code MGI

K913848 is an FDA 510(k) premarket notification submitted by Sharplan Lasers, Inc. for the device "SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR". The FDA issued a decision of Substantially Equivalent on March 27, 1992. The device falls under product code MGI (Aspirator, Ultrasonic), a Class III device. Sharplan Lasers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1992
Date Received
August 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspirator, Ultrasonic
Device Class
Class III
Regulation Number
Review Panel
OB
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)

FDA data resources