# K223540: AvalancheLase Family

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Jan 19, 2023 after 55 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: 25 generations back to K943450 (1995). 587 ancestors in all.
No later device cites it as a predicate yet.
0 of 588 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213267: Dynamis Pro Family, Fotona D.O.O. (2022) Summary page 5.
- K153671: Family of CoolGlide Aesthetic Lasers, Cutera, Inc. (2016) Summary page 5.
- K201111: GentleMax Pro Plus, Candela Corporation (2020) Summary page 5.
- K140732: Candela Gentlelase Family of Laser Systems, Candela Corp. (2014) Summary page 5.
- K162886: Deka Motus AX, El.En Electronic Engineering Spa (2017) Summary page 5.

## Indications for use
The AvalancheLase Family and its accessories will be marketed for the following indications for use: Alexandrite laser (755 nm wavelength): Indications in Dermatology and Aesthetics • Temporary hair reduction. • Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the 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. On all skin types (Fitzpatrick I- VI) including tanned skin. • Treatment of benign pigmented lesions. • Treatment of wrinkles • The photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG laser (1064 nm wavelength): The Nd:YAG laser module is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI. Indications in Dermatology and Aesthetics: • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regime. • Treatment of wrinkles. • Treatment of wrinkles with S11 (LX Runner) scanner. • Treatment of mild to moderate inflammatory acne vulgaris. • Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins. • Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - Radical nail excision - Periungual and subungual warts - Plantar warts - Neuromas • Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) NNd:YAG laser (1064 nm wavelength) therapy: • Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.

Source page: https://510kreport.com/device/K223540
Methodology: https://510kreport.com/methodology