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510(k) K161794

CENTURION Vision System (Active SentryTM) by Alcon Research, Ltd. — Product Code HQC

K161794 is an FDA 510(k) premarket notification submitted by Alcon Research, Ltd. for the device "CENTURION Vision System (Active SentryTM)". The FDA issued a decision of Substantially Equivalent on April 14, 2017. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Alcon Research, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2017
Date Received
June 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Alcon Research, Ltd.

  • K191650 — LEGION System (November 1, 2019)
  • K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitre (March 22, 2017)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121031 — WAVELIGHT FS200 PATIENT INTERFACE 1505 (June 21, 2012)
  • K112977 — MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (March 27, 2012)
  • K110951 — 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VAL (October 17, 2011)
  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K102860 — ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (May 10, 2011)
  • K101006 — WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 (October 21, 2010)
  • K093305 — ENHANCED ULTRA VIT PROBE (April 2, 2010)

Other clearances for product code HQC

  • K261264 — Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pac (May 15, 2026)
  • K252052 — Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, (March 25, 2026)
  • K250501 — System Sophi (November 14, 2025)
  • K243395 — MICOR 700 with Auto I/A (August 8, 2025)
  • K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-5062 (June 11, 2025)
  • K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (July 26, 2024)
  • K233398 — Faros Surgical System (June 27, 2024)
  • K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) (June 21, 2024)
  • K232084 — Stellaris Elite vision enhancement system (February 26, 2024)
  • K233902 — Centurion™ Vision System (Active Sentry™) (8065753057) (January 10, 2024)

FDA data resources