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510(k) K021936

MOIST PUNCTAL PLUG SYSTEM by Moist Medical, Inc. — Product Code LZU

K021936 is an FDA 510(k) premarket notification submitted by Moist Medical, Inc. for the device "MOIST PUNCTAL PLUG SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 2002. The device falls under product code LZU (Plug, Punctum), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2002
Date Received
June 12, 2002
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

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  • K161673 — LacriPro Punctum Plug (November 18, 2016)
  • K150288 — PDO Absorbable Punctum Plug (August 28, 2015)
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  • 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