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510(k) K170520

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ by Alcon Research, Ltd. — Product Code MLZ

K170520 is an FDA 510(k) premarket notification submitted by Alcon Research, Ltd. for the device "HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+". The FDA issued a decision of Substantially Equivalent on March 22, 2017. The device falls under product code MLZ (Vitrectomy, Instrument Cutter), a Class II device regulated under 21 CFR 886.4150. Alcon Research, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2017
Date Received
February 22, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vitrectomy, Instrument Cutter
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Alcon Research, Ltd.

  • K191650 — LEGION System (November 1, 2019)
  • K161794 — CENTURION Vision System (Active SentryTM) (April 14, 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 MLZ

  • K220030 — Vista Ophthalmics Vitrectomy Probe (May 4, 2022)
  • K093305 — ENHANCED ULTRA VIT PROBE (April 2, 2010)
  • K081681 — VITRECTOMY CUTTER AND ACCESSORIES (October 8, 2008)

FDA data resources