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510(k) K141954

XCEL 455 SLIT LAMP by Reichert, Inc. — Product Code HJO

K141954 is an FDA 510(k) premarket notification submitted by Reichert, Inc. for the device "XCEL 455 SLIT LAMP". The FDA issued a decision of Substantially Equivalent on October 15, 2014. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Reichert, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2014
Date Received
July 18, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Reichert, Inc.

  • K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (May 1, 2024)
  • K081756 — OCULAR RESPONSE ANALYZER (August 7, 2008)
  • K071839 — SOCT COPERNICUS, MODEL 15205 (February 27, 2008)
  • K070534 — MODIFICATION TO: OCU-FILM TIP COVER (March 27, 2007)
  • K063750 — XCEL 255 SLIT LAMP (December 20, 2006)
  • K061330 — PSL PORTABLE SLIT LAMP (May 25, 2006)
  • K042831 — ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) (October 28, 2004)
  • K032799 — NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER (January 20, 2004)

Other clearances for product code HJO

  • K253834 — VISUREF 600 (March 18, 2026)
  • K231760 — HP-OCT (HP-OCT) (March 8, 2024)
  • K222372 — Kowa SL-19 (November 21, 2022)
  • K193188 — MiiS Horus Eye Anterior Camera (January 14, 2020)
  • K182306 — Sunkingdom Slit Lamp (November 22, 2018)
  • K173771 — IOLMaster 700 (August 24, 2018)
  • K171877 — SLM-1ER, SLM-2ER, SLM-3ER (December 21, 2017)
  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
  • K162778 — Portable Slit Lamp Microscope (July 21, 2017)
  • K162684 — SL 220 (May 31, 2017)

FDA data resources