510(k) K220877

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems by Lumenis Be, Inc. — Product Code HQF

K220877 is an FDA 510(k) premarket notification submitted by Lumenis Be, Inc. for the device "Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems". The FDA issued a decision of Substantially Equivalent on July 15, 2022. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Lumenis Be, Inc. has at least 7 other 510(k) clearances on record.