# K113810: Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Inc.
- Decided: Mar 8, 2012 after 76 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: 15 generations back to K943450 (1995). 275 ancestors in all.
34 later devices descend from it; 1 cites it directly.
0 of 310 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.
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 1.
- K093545: Pinpointe Footlaser Model 6W, 30W, 100W, Incisive, Inc. (Formerly Named Incisive, LLC) (2010) Summary page 1.
- K110370: Q-Clear, Light Age, Inc. (2011) Summary page 1.
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 1.

## Most influential descendants
- K133837: Viora V-Total (2014), 33 descendants of its own
- K142093: V20 System (2014), 32 descendants of its own
- K150035: V10 system (2015), 31 descendants of its own
- K153568: InMode Plus System (2016), 18 descendants of its own
- K172302: InMode PLUS System (2017), 13 descendants of its own

## Indications for use
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Multi-Application Platform for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, podiatry, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications. The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) used with the Harmony XL™ Multi-Application Platform are indicated for use in: Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy Periungual and subungual warts Plantar warts Radical nail excision Neuromas The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) are intended for use with the Harmony XL™ Multi-Application Platform for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of. Benign vascular lesions such as, but not limited to treatment of: Port wine stains Hemangiomas Warts Superficial and deep telangiectasias (venulectasias) Reticular veins (0.1-4.0 mm dia.) of the leg Rosacea Venus lake Leg veins Spider veins Poikiloderma of Civatte Angiomas Benign cutaneous lesions, such as, but not limited to: Warts Scars Striae Psoriasis Benign pigmented lesions such as, but not limited to: Lentigos (age spots) Solar lentigos (sun spots) Cafe-au-lait macules Seborrheic keratoses Nevi and nevus of Ota Chloasma Verrucae Skin tags Keratoses The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos). Plaques Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles Perioral wrinkles Laser skin resurfacing procedures for the treatment of: Acne scars Wrinkles Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The 1064 nm Nd:YAG lasers (Long Pulsed only, with and without contact-cooling) is indicated for: Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Removal or lightening of unwanted hair (with and without adjuvant preparation) Treatment of pseudofolliculitis barbae (PFB)

Source page: https://510kreport.com/device/K113810
Methodology: https://510kreport.com/methodology