# K141425: Elite + Laser System

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: Sep 11, 2014 after 104 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). 1 ancestor in all.
44 later devices descend from it; 5 cite it directly.
0 of 46 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 4.

## 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
755 nm: The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064 nm: The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, 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), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis 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 treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K141425
Methodology: https://510kreport.com/methodology