# K241459: MOTUS PRO Family

- Pathway: 510(k) (Special)
- Applicant: El.En S.P.A.
- Decided: Jun 21, 2024 after 29 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: 21 generations back to K943450 (1995). 256 ancestors in all.
No later device cites it as a predicate yet.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211821: DEKA Motus AZ, El.En Electronic Engineering Spa (2021) Summary page 5.

## Indications for use
MOTUS PRO family is a medical laser family intended for: Alexandrite 755nm laser source: - Temporary hair reduction. - Stable long term or permanent hair reduction through selective targeting of melanin in hair follicles. - 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) included tanned skin. - Treatment of benign pigmented lesions. - Photocoagulation of benign dermatological vascular lesions (such as port wine stains, hemangiomas, telangiectasias). Nd:YAG 1064nm laser source: - Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzpatrick I-VI including tanned skin. - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasias, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. - The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patient with lesions that have not responded to other treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles.

Source page: https://510kreport.com/device/K241459
Methodology: https://510kreport.com/methodology