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510(k) K110166

CLEARCUT S SAFETY KNIFE by Alcon Research, Ltd. — Product Code HNN

K110166 is an FDA 510(k) premarket notification submitted by Alcon Research, Ltd. for the device "CLEARCUT S SAFETY KNIFE". The FDA issued a decision of Substantially Equivalent on May 20, 2011. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Alcon Research, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2011
Date Received
January 20, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
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)
  • 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)
  • 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 HNN

  • K922378 — OPHTHALMIC KNIFE (December 10, 1992)
  • K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE (August 22, 1988)
  • K881669 — MVR/STILETTO BLADE 20GA. - P/N 1900 (May 13, 1988)
  • K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE (April 13, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K871285 — KNIFE, OPHTHALMIC (April 27, 1987)
  • K864290 — RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (December 15, 1986)
  • K863725 — CATARACT DIAMOND KNIFE (October 31, 1986)

FDA data resources