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510(k) K210726

ImmersiveTouch by Immersivetouch, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2021
Date Received
March 11, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Immersivetouch, Inc.

  • K230249 — Ikshana (October 16, 2023)
  • K181813 — ImmersiveView Surgical Plan (IVSP®) (June 9, 2020)
  • K140860 — ImmersiveTouch3 and MicrovisTouch (December 16, 2014)

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  • K251577 — LAIA XR (February 6, 2026)
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