510(k) · Cleared
ClearedMattioli Pulse Two/Three Plus Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mattioli Engineering Corp. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Mar 10, 2010 after a 61-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Mar 10, 2010
- Review
- 61 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK100053 Mattioli Pulse Two/Three Plus FamilyMattioli Engineering Corp. · 2010
- Descendant · cites it directly · 1 of its ownK153717 Venus Versa SystemVenus Concept, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK232192 Venus Versa PRO SystemVenus Concept, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK152790 Venus Versa SystemVenus Concept, Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100053 | Mattioli Pulse Two/Three Plus Family | Mattioli Engineering Corp. | 2010 | — |
| +1 | K153717 | Venus Versa System | Venus Concept, Ltd. | 2016 | — |
| +2 | K232192 | Venus Versa PRO System | Venus Concept, Inc. | 2023 | — |
| +1 | K152790 | Venus Versa System | Venus Concept, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ONF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ONF device
- #1 K233473 Deka Lotusscore 18.1 · 27 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Advanced Technology Laser, Co., Ltd.: Angelite Family of Intense Pulsed Light Systems Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153717 (Venus Concept, Ltd., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (164 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100053: Mattioli Pulse Two/Three Plus Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100053
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026