# K100053: Mattioli Pulse Two/Three Plus Family

- Pathway: 510(k) (Traditional)
- Applicant: Mattioli Engineering Corp.
- Decided: Mar 10, 2010 after 61 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Advanced Technology Laser, Co., Ltd.: Angelite Family of Intense Pulsed Light Systems: named in the summary without a submission number

## Most influential descendants
- K153717: Venus Versa System (2016), 1 descendant of its own
- K232192: Venus Versa PRO System (2023), 0 descendants of its own
- K152790: Venus Versa System (2016), 0 descendants of its own

## Indications for use
The MATTIOLI PULSE TWO/THREE PLUS is an Intense Pulse Light (IPL) device family indicated for use in aesthetic applications (based on selective photothermolysis) , in the treatment of various benign pigmented lesions and hair removal and that produce different effects depending on the applicator that is used: SA APPLICATOR: Model SN: Wavelengths from 560 - 1200 nm are indicated for treatment of benign pigmente (epidermal and coutaneous) lesions, including hyperpigmentation, warts, lentigines, nevi, melasma, and cafe-au-lait. VA APPLICATOR Model VN: Wavelengths from 510 - 1200 nm are indicated for the treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomnas and spider anglormas, polkiloderma of civatte; leg veins, facial veins and venous malformations. HR APPLICATORS indicated for the treatment of unwanted hair (i.e. hair removal). Model [IN: Wavelengths from 650-1200 nm for skin types I-IV; Model HF: Wavelengths from 710 - 1200 nim for skin type V The equipment should only be used under medical supervision.

Source page: https://510kreport.com/device/K100053
Methodology: https://510kreport.com/methodology