# K123777: Multilaser System

- Pathway: 510(k) (Traditional)
- Applicant: Ultralight Laser Technologies, LLC
- Decided: Apr 11, 2013 after 122 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: 11 generations back to K910422 (1992). 123 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110502: Triplex ER. Yag / ND: Yag System, Sandstone Medical Technologies, LLC (2011) Summary page 3.
- K110304: Apex ER. Yag / Ipl System, Sandstone Medical Technologies, LLC (2011) Summary page 4.
- K100893: Cheveux Diode Laser System, Sandstone Medical Technologies, LLC (2010) Summary page 3.

## Most influential descendants
- K233143: PiXel8-Reveal (2024), 0 descendants of its own

## Indications for use
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery). The Nd:YAG handpiece is indicated for: * At the 1064 nm wavelength - dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair. * At the 532 nm wavelength - removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes) The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for: * Hair Removal * Permanent hair reduction * Treatment of vascular lesions * Treatment of benign pigmented lesions * Treatment of Leg Veins * Treatment for pseudofolliculitis barbae The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications: * Hair Removal (650nm filter) * Permanent hair reduction (650nm filter) * Treatment of vascular lesions (510nm filter) * Treatment of benign pigmented lesions (510 nm filter) * Mild to Moderate inflammatory acne (450nm filter)

Source page: https://510kreport.com/device/K123777
Methodology: https://510kreport.com/methodology