FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES— 510(k) K051944

Name: FDA 510(k) clearance K051944
Creator: U.S. Food and Drug Administration
Published: 2005-09-30

Substantially Equivalent

Lumenis, Inc.

FDA 510(k) clearance K051944 for FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES, Substantially Equivalent on 2005-09-30. Applicant: Lumenis, Inc.. Device class: 2.

Clearance details

Applicant: Lumenis, Inc.
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 2005-07-18
Decision date: 2005-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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