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

Name: FDA 510(k) clearance K220877
Creator: U.S. Food and Drug Administration
Published: 2022-07-15

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.. Device class: 2.

Clearance details

Applicant: Lumenis Be, Inc.
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
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 ↗

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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.