# K090235: Elite MPX Laser System with XPL Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Mar 17, 2009 after 43 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
Longest line of descent: 1 generation back to K034030 (2004). 2 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.
- K051442: Photosilk Plus Pulsed Light System and Laser Attachment, Cynosure, Inc. (2006)

## Most influential descendants
- K152012: EVO platform (2015), 37 descendants of its own
- K160368: EVO platform (2016), 36 descendants of its own
- K163222: Discovery Pico Family (2016), 30 descendants of its own
- K171945: Discovery Pico, Discovery Pico Plus (2017), 21 descendants of its own
- K172376: Discovery Pico, Discovery Pico Plus (2017), 20 descendants of its own

## Indications for use
Elite MPX 755 nm: The Elite MPX Laser system is indicated for.stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - IV) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. Elite MiPX 1064 nm: The Elite MPX laser system 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 warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as , but not limited to, lentigos (age spots), solar lentigos (sun spots), cafd au lait macules, 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 indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in the hair follicles, and for the treatment of pseudofolliclitis (PFB). XPL Handpiece: The XPL Pulsed Light handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.

Source page: https://510kreport.com/device/K090235
Methodology: https://510kreport.com/methodology