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510(k) K040231

INTELIPORT OCCLUDING DEVICE by Alcon, Inc. — Product Code LZU

K040231 is an FDA 510(k) premarket notification submitted by Alcon, Inc. for the device "INTELIPORT OCCLUDING DEVICE". The FDA issued a decision of Substantially Equivalent on July 13, 2004. The device falls under product code LZU (Plug, Punctum), a Class U device. Alcon, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2004
Date Received
February 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Punctum
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Other clearances by Alcon, Inc.

  • K063583 — ALCON VISION SYSTEM (May 9, 2008)
  • K071236 — ALCON MULTI-PURPOSE SOLUTION (December 12, 2007)
  • K031193 — SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION (July 3, 2003)
  • K981574 — OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION (July 6, 1998)

Other clearances for product code LZU

  • K241229 — Hello,eyes® BIO Plug (June 28, 2024)
  • K222164 — Visant Medical Canalicular Plug (December 23, 2022)
  • K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (June 3, 2022)
  • K190210 — Tear Pool Dissolvable Punctum Plugs (October 24, 2019)
  • K162361 — Soft Plug Extended Duration 180 Canalicular Plug (April 17, 2017)
  • K161673 — LacriPro Punctum Plug (November 18, 2016)
  • K150288 — PDO Absorbable Punctum Plug (August 28, 2015)
  • K140352 — VERAPLUG (November 13, 2014)
  • K140711 — COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLU (June 20, 2014)
  • K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (June 3, 2014)

FDA data resources