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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 the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Inc.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) 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. The listed applicant is Lumenis Be, Inc.. The 510(k) number is K220877.

When did Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems?

The FDA 510(k) record lists Lumenis Be, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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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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