# K170850: Alma Q

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Jun 15, 2017 after 85 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: 9 generations back to K910422 (1992). 101 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040384: Mydon C, Wavelight Laser Technologie AG (2004) Summary page 5.
- K032667: Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow), Focus Medical, LLC (2004) Summary page 5.
- K992597: Lorad LT-100 Laser Treatment System, Focus Medical, LLC (2000) Summary page 5.

## Most influential descendants
- K233024: Alma Harmony (2024), 1 descendant of its own
- K252561: BTL-754FF (2026), 0 descendants of its own

## Indications for use
The Alma Q laser is intended for use in aesthetic 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. LP1064nm 1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. 2. The Alma Q laser system is also indicated for the treatment of wrinkles. 3. The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). 4. The Alma Q laser system is indicated for use on all skin types (Fitzpatrick VI), including tanned skin. 5. The intended use of the integral cooling system in the Alma Q laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments. QS 532nm 1. Tattoo removal -Red inks -Blue and light blue inks -Green inks 2. Treatment of benign vascular lesions -Telangiectasias -Spider angiomas -Cherry angiomas -Spider nevi 3. Treatment of benign pigmented lesions -Cafe-au-lait birthmarks -Solar lentigines -Becker's nevi -Freckles -Nevus spilus -Nevus of ota 4. Incision, excision, ablation, and vaporization of soft tissue in general dermatology QS 1064nm The Alma Q laser treatment system is intended for use: For the removal or lightening of unwanted facial or body hair. For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, Benign dermal pigmented lesions (dermal melanocytosis); and For tattoo removal (dark and blue inks).

Source page: https://510kreport.com/device/K170850
Methodology: https://510kreport.com/methodology