# K142860: Lumenis M22 System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Jan 21, 2015 after 112 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K910422 (1992). 321 ancestors in all.
38 later devices descend from it; 6 cite it directly.
0 of 360 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060448: Lumenis One Family of Systems; Lumenis One., Lumenis, Ltd. (2006) Summary page 8.
- K083733: Lume 2 System, Model GA0005000, Lumenis, Ltd. (2009) Summary page 7.
- K130028: Resurfx 1565NM Laser Module, Lumenis, Ltd. (2013) Summary page 7.
- K043173: Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum Series, Lumenis, Ltd. (2005) Summary page 7.
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 8.
- K063074: Candela 3630 Laser System, Candela Corp. (2006) Summary page 8.

## Most influential descendants
- K170060: M22 and ResurFx Systems (2017), 24 descendants of its own
- 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
- K192539: Deka Luxea (2019), 4 descendants of its own

## Recalls of this device
- Nov 17, 2015 · Class II · Z-1669-2016: Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.

## 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: 1. The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 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) 2. 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 3. ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: • Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue 4. 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 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 regime.

Source page: https://510kreport.com/device/K142860
Methodology: https://510kreport.com/methodology