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510(k) K062930

LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM by Alcon Research, Ltd. — Product Code NCF

K062930 is an FDA 510(k) premarket notification submitted by Alcon Research, Ltd. for the device "LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 8, 2006. The device falls under product code NCF (Aberrometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Alcon Research, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2006
Date Received
September 28, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aberrometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
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)
  • 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)

Other clearances for product code NCF

  • K050336 — OPD-STATION SOFTWARE (August 24, 2005)
  • K023249 — ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (October 18, 2002)
  • K000637 — CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (May 19, 2000)

FDA data resources