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

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..

Clearance details

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

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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.