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FDA 510(k)

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

K-Number: K220877 · 2022-07-15

ApplicantLumenis Be, Inc.
Decision Date2022-07-15
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems is a medical device manufactured by Lumenis Be, Inc.. It received FDA 510(k) clearance on 2022-07-15 under approval number K220877. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems?

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Lumenis Be, Inc.. The 510(k) number is K220877.

When was Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems approved by the FDA?

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems received FDA 510(k) clearance on 2022-07-15, under approval number K220877.

What company makes Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems?

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems is manufactured by Lumenis Be, Inc..

What is the FDA product code for Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems?

The FDA product code for Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems is HQF.

Related Clinical Trials

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Related PubMed Literature

PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026) PMID: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (2026) PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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