Home / 510(k) Clearances / K101561

510(k) K101561

TX1 TISSUE REMOVAL SYSTEM by American Optisurgical, Inc. — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2010
Date Received
June 4, 2010
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 American Optisurgical, Inc.

  • K080803 — VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 (September 22, 2008)
  • K020527 — HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 (July 9, 2002)
  • K953539 — DM001 DISPOSABLE PACK (December 26, 1995)
  • K953538 — RM001 REUSABLE (December 26, 1995)
  • K952331 — AOI LC-40 PHACOEMULSIFIER (August 16, 1995)

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)