# K050779: Cynergy Multiplex Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jun 27, 2005 after 91 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cynosure Cynergy laser: named in the summary without a submission number

## Most influential descendants
- K180593: Vbeam Prima Laser System (2018), 2 descendants of its own
- K183452: Vbeam Prima Laser System (2019), 1 descendant of its own
- K230990: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) (2023), 0 descendants of its own

## Indications for use
585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal. 1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), caf6 au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is intended for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB). 585 - 600nm with 1,064nm Wavelength Multiplex Mode: The wavelength multiplex mode is intended for benign vascular and vascular dependant lesions removal.

Source page: https://510kreport.com/device/K050779
Methodology: https://510kreport.com/methodology