# K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: Jan 16, 2020 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: 20 generations back to K910422 (1992). 323 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 336 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170060: M22 and ResurFx Systems, Lumenis, Ltd. (2017) Summary page 5.

## Most influential descendants
- K202884: SR-1 Skin Treatment System (2021), 4 descendants of its own
- K222790: F65 Laser System (2023), 3 descendants of its own
- K221268: SR-1 Skin Treatment System (2022), 3 descendants of its own
- K223871: Miria Skin Treatment System (2023), 2 descendants of its own
- K250402: AVAVA™ Skin Treatment System (2025), 1 descendant of its own

## Indications for use
The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 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, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles Mild to moderate inflammatory Acne (Acne vulgaris) The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) 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 removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles The non-ablative treatment of facial wrinkles ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: Removal of dark tattoos Treatment of pigmented lesions *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

Source page: https://510kreport.com/device/K193500
Methodology: https://510kreport.com/methodology