Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems— 510(k) K220877

Substantially Equivalent

Lumenis Be, Inc.

FDA 510(k) clearance K220877 for Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems, Substantially Equivalent on 2022-07-15. Applicant: Lumenis Be, Inc..

Clearance details

Applicant: Lumenis Be, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2022-03-25
Decision date: 2022-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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.