510(k) K021831

OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB by Lacrimedics, Inc. — Product Code LZU

K021831 is an FDA 510(k) premarket notification submitted by Lacrimedics, Inc. for the device "OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB". The FDA issued a decision of Substantially Equivalent on July 1, 2002. The device falls under product code LZU (Plug, Punctum), a Class U device. Lacrimedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2002
Date Received
June 4, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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