# K221571: InMode Multi-system

- Pathway: 510(k) (Special)
- Applicant: InMode, Ltd.
- Decided: Jun 30, 2022 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: 23 generations back to K943450 (1995). 643 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 646 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180719: InMode Diolaze System, Inmode MD, Ltd. (2018) Summary page 5.
- K173677: InMode VLaze, Inmode MD, Ltd. (2018) Summary page 5.
- K123860: Inmode SR Ipl Device, Inmode MD, Ltd. (2013) Summary page 5.
- K200947: InMode System with the Morhpeus8 Applicators, InMode, Ltd. (2020) Summary page 5.
- K180189: InMode System with Fractora3D/3D-90 Applicators, Inmode MD, Ltd. (2018) Summary page 5.
- K151273: InMode FRF Applicator, Inmode MD, Ltd. (2016) Summary page 5.
- K102461: Fractora, Invasix, Ltd. (2011) Summary page 5.
- K131362: Inmode Wmbody Device, Inmode MD, Ltd. (2013) Summary page 5.
- K160329: InMode System MiniFX Handpiece, Inmode MD, Ltd. (2016) Summary page 5.
- K172302: InMode PLUS System, Inmode MD, Ltd. (2017) Summary page 5.
- K210492: InMode RF Pro System, Inmode MD, Ltd. (2021) Summary page 5.
- K140926: Inmode Wmface Device, Inmode MD, Ltd. (2014) Summary page 5.

## Most influential descendants
- K251632: Optimas MAX System (2025), 1 descendant of its own
- K252215: InbellaMAX System (2025), 0 descendants of its own

## Indications for use
The InMode Multi System with the Diode laser Applicators is indicated for: Diolaze XL. 810nm Applicator is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal. VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The InMode Multi System with the IPL. Applicator is indicated for: [PL Applicator with wavelengths (515-1200nm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations. The InMode Multi System with the non-invasive RF Applicators is indicated for: BodyFX (WMBody) and MiniFX Applicators are intended for the treatment of the following medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite. PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids. The InMode Multi System with the Fractional RF Applicators is indicated for: FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K221571
Methodology: https://510kreport.com/methodology