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510(k) K232717

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) by Changzhou Haili Medical Co., Ltd. — Product Code LQY

K232717 is an FDA 510(k) premarket notification submitted by Changzhou Haili Medical Co., Ltd. for the device "Apex Locator (AL-Pex), Apex Locator (AL-Pex+)". The FDA issued a decision of Substantially Equivalent on December 22, 2023. The device falls under product code LQY (Locator, Root Apex), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
September 5, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Locator, Root Apex
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances for product code LQY

  • K252224 — Apex Locator (FindPex) (April 8, 2026)
  • K242383 — Apex Locator (March 7, 2025)
  • K242765 — Electronic Apex Locator (Alpha Apex I) (January 17, 2025)
  • K231990 — Apex Locator (February 13, 2024)
  • K212178 — Root Apex Locator (July 20, 2022)
  • K210789 — EQ-PEX (October 20, 2021)
  • K203836 — BOMEDENT Apex locator, WISMY Apex locator (March 30, 2021)
  • K191806 — Propex IQ Apex Locator (October 3, 2019)
  • K181087 — Apex Locator, DPEX III (December 18, 2018)
  • K171867 — Dr’s Finder NEO (March 30, 2018)

FDA data resources