510(k) · Cleared
ClearedMilesman Premium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milesman S.L. · GEX Powered Laser Surgical Instrument
Cleared on Dec 4, 2007 as substantially equivalent to K003614 (Coherent Star, 2001) after an 11-day review. Its family tree reaches back 1 generation to 2001. 6 later devices descend from it.
- Decided
- Dec 4, 2007
- Review
- 11 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003614 (2001). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003614 Lightsheer Pulsed Diode Array Laser SystemCoherent Star · 2001 · Recalled
- This deviceK073300 Milesman PremiumMilesman S.L. · 2007
- Descendant · cites it directly · 4 of its ownK120622 Palomar Vectus LaserPalomar Medical Technologies, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK193426 Elite iQCynosure, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK162765 Venus Velocity Diode Laser SystemVenus Concept, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK240396 Elite iQ PRO (M122K1)Cynosure, LLC · 2024
- Descendant · cites it directly · 0 of its ownK203804 Global Med Systems Milesman Compact LaserGlobal Med Systems SL · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120622Palomar Vectus LaserPalomar Medical Technologies, Inc. · 2012 · cites it directly4descendants
- K193426Elite iQCynosure, LLC · 2020 · 2 generations on1descendant
- K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd. · 2017 · 2 generations on1descendant
- K240396Elite iQ PRO (M122K1)Cynosure, LLC · 2024 · 3 generations on0descendants
- K203804Global Med Systems Milesman Compact LaserGlobal Med Systems SL · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003614 | Lightsheer Pulsed Diode Array Laser System | Coherent Star | 2001 | 2 |
| 0 (this device) | K073300 | Milesman Premium | Milesman S.L. | 2007 | — |
| +1 | K120622 | Palomar Vectus Laser | Palomar Medical Technologies, Inc. | 2012 | — |
| +2 | K193426 | Elite iQ | Cynosure, LLC | 2020 | — |
| +2 | K162765 | Venus Velocity Diode Laser System | Venus Concept, Ltd. | 2017 | — |
| +3 | K240396 | Elite iQ PRO (M122K1) | Cynosure, LLC | 2024 | — |
| +1 | K203804 | Global Med Systems Milesman Compact Laser | Global Med Systems SL | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K003614 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…Product Code: GEX Review Panel: General & Plastic Surgery 3. Predicate Device Information: K#003614, LightSheer T M Pulsed Diode Array Laser System 4. Device Description: The Milseman Premium Pulsed Diode Array Laser… | 2001 |
What descends from it? (6)
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Milesman Premium Pulsed Diode Array Laser System is intended for use in
general and plastic surgery and dermatology procedures for the treatment of
vascular lesions, such as angiomas, hemangiomas, telangiectasia and other
benign vascular lesions and treatment for pseudofolliculitis barbae.
The Milesman Premium is also used for removal of unwanted hair, permanent
hair reduction and the treatment of benign pigmented lesions and leg veins
in all skin types (Fitzpatrick I-VI), including tanned skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073300: Milesman Premium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073300
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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