# K103626: Cutera Genesisplus Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Apr 5, 2011 after 116 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- 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: 8 generations back to K936109 (1994). 110 ancestors in all.
121 later devices descend from it; 7 cite it directly.
0 of 232 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 1.
- K093545: Pinpointe Footlaser Model 6W, 30W, 100W, Incisive, Inc. (Formerly Named Incisive, LLC) (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K083545: Ziehm Vision RFD, Ziehm Imaging, Inc. (2009). Our OCR of the scanned summary read K083545, FDA’s number for Ziehm Vision RFD (Ziehm Imaging, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PinPointe Footlaser”. Kept off the family tree. Summary page 3.

## Most influential descendants
- K113702: Fotona XP ND: Yag Laser System (2012), 65 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K113810: Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules (2012), 34 descendants of its own
- K133837: Viora V-Total (2014), 33 descendants of its own
- K120235: Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo, Lightpod ND: Yag Lasers, Lightp (2012), 33 descendants of its own

## Indications for use
The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of genera! and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications. Dermatoloqgy: The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte,, and treatment of benign cutaneous lesions, such as warts, scars and straie. The laser is also intended for the treatment of benign pigmented lesions. 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-V1), including tanned skin. Podiatry: Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: * Matrixectomy * Periungual and subungual warts o Plantar warts * Radical nail excision e Neuromas The Cutera 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, efc.).

Source page: https://510kreport.com/device/K103626
Methodology: https://510kreport.com/methodology