# K251632: Optimas MAX System

- Pathway: 510(k) (Special)
- Applicant: InMode, Ltd.
- Decided: Jun 26, 2025 after 29 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: 24 generations back to K943450 (1995). 645 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 647 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221571: InMode Multi-system, InMode, Ltd. (2022) Summary page 5.
- K231790: The InMode System with the Morpheus8 Applicators, InMode, Ltd. (2023) Summary page 5.

## Most influential descendants
- K252215: InbellaMAX System (2025), 0 descendants of its own

## Indications for use
The Optimas MAX System with the Diolaze XL MAX 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. The Fusion Light and the Fusion Dark are intended for hair removal. The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The Optimas MAX System with the Lumecca Peak Applicators are 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, poikiloderma of Civatte, superficial leg veins and venous malformations. The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation The Optimas MAX System with the he Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K251632
Methodology: https://510kreport.com/methodology