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510(k) K850649

ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT by Lacrimedics, Inc.

K850649 is an FDA 510(k) premarket notification submitted by Lacrimedics, Inc. for the device "ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT". The FDA issued a decision of Substantially Equivalent on May 21, 1985. Lacrimedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1985
Date Received
February 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Lacrimedics, Inc.

  • K161673 — LacriPro Punctum Plug (November 18, 2016)
  • K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (June 3, 2014)
  • K030300 — OPAQUE HERRICK LACRIMAL PLUG (May 9, 2003)
  • K021831 — OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-O (July 1, 2002)
  • K001737 — OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM (June 19, 2000)
  • K963501 — HERRICK ULTIMATE PUNCTUM PLUG (April 14, 1997)
  • K963708 — HERRICK ULTIMATE PUNCTUM PLUG (April 14, 1997)
  • K944402 — FOCOMETER (November 22, 1994)
  • K896175 — HERRICK LACRIMAL PLUG TM. (January 22, 1990)
  • K895342 — COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST (November 2, 1989)

FDA data resources