Class Class II

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) (K230990)

K230990 2023-06-01 Traditional
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Description

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) by Candela Corporation, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230990
Clearance Date2023-06-01
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810

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Predicate lineage for K230990

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) (K230990) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K183452Vbeam Prima Laser SystemCandela Corp.2019
K050673CANDELA FAMILY OF PULSE DYE LASER SYSTEMSCandela Corp.2005

Trace the full predicate network for K230990

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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