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510(k) K240512

Tixel i (TXLI0001) by Novoxel , Ltd. — Product Code ORZ

K240512 is an FDA 510(k) premarket notification submitted by Novoxel , Ltd. for the device "Tixel i (TXLI0001)". The FDA issued a decision of Substantially Equivalent on November 4, 2024. The device falls under product code ORZ (Eyelid Thermal Pulsation System), a Class II device regulated under 21 CFR 886.5200. Novoxel , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2024
Date Received
February 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eyelid Thermal Pulsation System
Device Class
Class II
Regulation Number
886.5200
Review Panel
OP
Submission Type

Therapeutic application of heat and massage to the eyelids.

Other clearances by Novoxel , Ltd.

  • K223033 — Tixel® 2 System (June 21, 2023)
  • K202988 — Tixel System (February 25, 2021)

Other clearances for product code ORZ

  • K252409 — TearCare MGX System (April 27, 2026)
  • K242786 — TearCare MGX System (April 15, 2025)
  • K231084 — TearCare MGX System (December 27, 2023)
  • K213045 — TearCare System (December 21, 2021)
  • K200400 — Systane iLux2 (May 21, 2020)
  • K192623 — LipiFlow Thermal Pulsation System (October 22, 2019)
  • K172645 — iLux Instrument, iLux Disposable (December 26, 2017)
  • K161357 — LipiFlow Thermal Pulsation System (November 4, 2016)
  • K133127 — LIPIFLOW THERMAL PULSATION SYSTEM (December 23, 2013)
  • K112704 — LIPIFLOW THERMAL PULSATION SYSTEM (December 19, 2011)

FDA data resources