# K170060: M22 and ResurFx Systems

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: Aug 9, 2017 after 215 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 K910422 (1992). 322 ancestors in all.
24 later devices descend from it; 5 cite it directly.
0 of 347 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142860: Lumenis M22 System, Lumenis, Ltd. (2015) Summary page 5.
- K130028: Resurfx 1565NM Laser Module, Lumenis, Ltd. (2013) Summary page 5.

## Most influential descendants
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System (2020), 12 descendants of its own
- K203441: The Alma Hybrid Laser System (2021), 5 descendants of its own
- 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

## Indications for use
The subject Lumenis M22 System 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 400-1200nm (with 10 different filters) is indicated for: Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos 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 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 from all skin types, and to effect stable 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 1064nm 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 the completion of a treatment regime. The ResurFX System with wavelength of 1565 nm, is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

Source page: https://510kreport.com/device/K170060
Methodology: https://510kreport.com/methodology