510(k) · Cleared
Recalled · Class II · 2012Quanta System Etrna Giovinezza
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta System Spa · GEX Powered Laser Surgical Instrument
Cleared on Jan 4, 2006 after a 247-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 4, 2006
- Review
- 247 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK051113 Quanta System Etrna GiovinezzaQuanta System Spa · 2006
- Descendant · cites it directly · 2 of its ownK080638 CLAROClrs Technology Corporation · 2008
- Descendant · 2 generations on · 1 of its ownK090744 CLAROClrs Technology Corporation · 2010
- Descendant · 3 generations on · 0 of its ownK150282 Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK062721 Greenton Ecolite Ipl SystemGreenton (London), Ltd. · 2006
Most influential descendants
Showing 4 of 4 · See all- K080638CLAROClrs Technology Corporation · 2008 · cites it directly2descendants
- K090744CLAROClrs Technology Corporation · 2010 · 2 generations on1descendant
- K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc. · 2015 · 3 generations on0descendants
- K062721Greenton Ecolite Ipl SystemGreenton (London), Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051113 | Quanta System Etrna Giovinezza | Quanta System Spa | 2006 | — |
| +1 | K080638 | CLARO | Clrs Technology Corporation | 2008 | — |
| +2 | K090744 | CLARO | Clrs Technology Corporation | 2010 | — |
| +3 | K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | Shaser, Inc. | 2015 | — |
| +1 | K062721 | Greenton Ecolite Ipl System | Greenton (London), Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | — | Palomar Medical Products, Inc. Named without a submission number | |
| * | — | Cynlosure, Inc. Named without a submission number |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2012 | Class II | Z-0692-2013 | Labeling False and Misleading | Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080638 (Clrs Technology Corporation, 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Quanta System Etema Giovinezza system is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
It is also indicated for treatment of inflammatory acne (acne vulgaris) and cutaneous lesions, including warts, scars, and striae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051113: Quanta System Etrna Giovinezza.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051113
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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