# K122493: Genesisplus

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: May 15, 2013 after 272 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: 9 generations back to K936109 (1994). 111 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103626: Cutera Genesisplus Laser System, Cutera, Inc. (2011) Summary page 1.

## Most influential descendants
- K140122: Candela Gentlemax Family of Laser System (2014), 10 descendants of its own
- K150907: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (2015), 5 descendants of its own
- K161162: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (2016), 4 descendants of its own
- K201111: GentleMax Pro Plus (2020), 3 descendants of its own
- K192856: MT One (2020), 2 descendants of its own

## Indications for use
The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopiclaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications. Dermatology: The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloid scars), and warts. The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. PodilatrV: Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: * Matrixectomy * Periungual and subungual warts * Plantar warts * Radical nail excision * Neuromas The Cuterat GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g-, dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans. etc.).

Source page: https://510kreport.com/device/K122493
Methodology: https://510kreport.com/methodology