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510(k) K092433

DYSIS by Forth Photonics Hellas SA — Product Code HEX

K092433 is an FDA 510(k) premarket notification submitted by Forth Photonics Hellas SA for the device "DYSIS". The FDA issued a decision of Substantially Equivalent on March 10, 2011. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2011
Date Received
August 7, 2009
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 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)
  • K143119 — LT-300 Video Colposcope (December 18, 2014)

FDA data resources