# K250809: Stellar M22

- Pathway: 510(k) (Special)
- Applicant: Lumenis Be, Ltd.
- Decided: Apr 16, 2025 after 30 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 K910422 (1992). 324 ancestors in all.
No later device cites it as a predicate yet.
0 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System, Lumenis, Ltd. (2020) Summary page 6.

## Indications for use
The Lumenis Stellar M22 system has connection capability with the following available treatment modules, for multi-application treatment options. All modules are designed for aesthetic and dermatological skin procedure application, as follows: Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). Cutaneous lesions, including warts, scars and striae. Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types |-V through selective targeting of melanin in hair follicles. Mild to moderate inflammatory Acne (Acne Vulgaris). Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm is indicated for: The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg. The non-ablative treatment of facial wrinkles. The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types |-V through selective targeting of melanin in hair follicles. The 1565nm ResurFX module, with a wavelength of 1565 nm, is indicated for: Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. Q-Switched Nd:YAG Laser, with a wavelength of 1064 nm, is indicated for: Treatment of pigmented lesions. Removal of dark tattoos. (*) 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 regimen.

Source page: https://510kreport.com/device/K250809
Methodology: https://510kreport.com/methodology