# K123860: Inmode SR Ipl Device

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Apr 2, 2013 after 109 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 8 generations back to K910422 (1992). 64 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 1.

## Most influential descendants
- K221571: InMode Multi-system (2022), 2 descendants of its own
- K251632: Optimas MAX System (2025), 1 descendant of its own
- K252215: InbellaMAX System (2025), 0 descendants of its own

## Indications for use
The InMode SR IPL Device wavelengths (515-1 200nm) are indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpignientation, 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.

Source page: https://510kreport.com/device/K123860
Methodology: https://510kreport.com/methodology