# K161632: FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Dec 8, 2016 after 178 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: 19 generations back to K943450 (1995). 288 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150516: Deka Synchro Repla:Y Family of Laser Systems, El.En Electronic Engineering Spa (2015) Summary page 5.
- K140122: Candela Gentlemax Family of Laser System, Candela Corp. (2014) Summary page 5.

## Most influential descendants
- K241407: Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (2024), 0 descendants of its own

## Indications for use
The Nd:Yag 1064 Laser is intended for: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. - Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. The Nd:Yag 1064 Laser is intended for: - Temporary increase of clear nail in patients with onychomycosis (e.g., derniatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.) The Alexandrite 755 laser is intended for: - 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) including tanned skin. - Treatment of benign pigmented lesions. - Treatment of wrinkles. - Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Source page: https://510kreport.com/device/K161632
Methodology: https://510kreport.com/methodology