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510(k) K143119

LT-300 Video Colposcope by Lutech Industries, Inc. — Product Code HEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2014
Date Received
October 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colposcope (And Colpomicroscope)
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type

Other clearances by Lutech Industries, Inc.

  • K170446 — LT-300 SD Digital Video Colposcope (May 21, 2017)
  • K160380 — LT-300 HD (May 13, 2016)
  • K150691 — Datalys Multi-Parameter Patient Monitor (May 15, 2015)

Other clearances for product code HEX

  • K233043 — Smart Scope® CX (June 14, 2024)
  • K190187 — Gynescope System (May 8, 2019)
  • K182764 — Biop Digital Colposcope (November 27, 2018)
  • K181034 — Pocket Colposcope System (September 21, 2018)
  • K170446 — LT-300 SD Digital Video Colposcope (May 21, 2017)
  • K161871 — EVA (Enhanced Visual Assessment) System (December 19, 2016)
  • K160341 — Colposcope System (September 14, 2016)
  • K160380 — LT-300 HD (May 13, 2016)
  • K151878 — Video Colposcope (December 1, 2015)
  • K140754 — COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM (October 23, 2014)