DeviceClearance

COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST— 510(k) K895342

Substantially Equivalent

Lacrimedics, Inc.

FDA 510(k) clearance K895342 for COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST, Substantially Equivalent on 1989-11-02. Applicant: Lacrimedics, Inc.. Device class: Unclassified.

Clearance details

Applicant
Lacrimedics, Inc.
Product code
Code LZU
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rosemead, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LZU

product code LZU
Other
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K895342

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K895342.

Data sourced from openFDA. This site is unofficial and independent of the FDA.