510(k) · Cleared
ClearedSynchro HP Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En Electronic Engineering Spa · GEX Powered Laser Surgical Instrument
Cleared on Mar 20, 2009 as substantially equivalent to K033172 (Candela Corp., 2003) and 2 other predicates after a 245-day review. Its family tree reaches back 15 generations to 1995. 19 later devices descend from it.
- Decided
- Mar 20, 2009
- Review
- 245 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K943450 (1995). 240 ancestors in all, the oldest K800617 (1980). 19 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK082039 Synchro HP PlatformEl.En Electronic Engineering Spa · 2009
- Descendant · cites it directly · 18 of its ownK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- Descendant · 2 generations on · 17 of its ownK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- Descendant · 3 generations on · 16 of its ownK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
- Descendant · 2 generations on · 4 of its ownK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
- Descendant · 4 generations on · 2 of its ownK233090 DEKA AGAIN PRO familyEl.En S.P.A. · 2023
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK082039 Synchro HP PlatformEl.En Electronic Engineering Spa · 2009
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K103288Deka Synchro FTEl.En Electronic Engineering Spa · 2011 · cites it directly18descendants
- K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013 · 2 generations on17descendants
- K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015 · 3 generations on16descendants
- K192539Deka LuxeaEl.En Electronic Engineering Spa · 2019 · 2 generations on4descendants
- K233090DEKA AGAIN PRO familyEl.En S.P.A. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | K082039 | Synchro HP Platform | El.En Electronic Engineering Spa | 2009 | — |
| +1 | K103288 | Deka Synchro FT | El.En Electronic Engineering Spa | 2011 | — |
| +2 | K131095 | Deka Synchro Repla: Y Family of Laser Systems | El.En Electronic Engineering Spa | 2013 | — |
| +3 | K150516 | Deka Synchro Repla:Y Family of Laser Systems | El.En Electronic Engineering Spa | 2015 | — |
| +2 | K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019 | — |
| +4 | K233090 | DEKA AGAIN PRO family | El.En S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 11 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 30 | 0 |
| 2003 | 21 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K033172 | Candela Gentleyag Family of Laser SystemsSummary page 1…Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810 Equivalent Devices: K033172 - Candela Gentle YAG Family of Lasers K051442 - Cynosure Photosilk Plus Pulsed Light & Laser Attachment… | 2003 |
| * | K051442 | Photosilk Plus Pulsed Light System and Laser AttachmentSummary page 1…79-GEX 21 CFR 878.4810 Equivalent Devices: K033172 - Candela Gentle YAG Family of Lasers K051442 - Cynosure Photosilk Plus Pulsed Light & Laser Attachments K072564 - Alma Lasers Harmony XL Multi-Appli… | 2006 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 1…K033172 - Candela Gentle YAG Family of Lasers K051442 - Cynosure Photosilk Plus Pulsed Light & Laser Attachments K072564 - Alma Lasers Harmony XL Multi-Application Platform Device Description: The Synchro HP Platform laser and pulsed light sys… | 2008 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103288 | Deka Synchro FT | 2011 | 18 |
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?
- The line of descent spans 14 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 9 of the 240 ancestors have a recall of any class.
- Of its descendants, K103288 (El.En Electronic Engineering Spa, 2011) has gone furthest, with 18 descendants of its own.
- 9 other devices also cite its predicate K033172.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Nd:YAG Laser (1064 nm): removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions; Er:YAG Laser attachment (2940 nm): skin resurfacing and incision, excision, ablation or vaporization of soft bodily tissues. Q-switched Nd:YAG…
Read the full statement (214 words)
Nd:YAG Laser (1064 nm): removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions;
Er:YAG Laser attachment (2940 nm): skin resurfacing and incision, excision, ablation or vaporization of soft bodily tissues.
Q-switched Nd:YAG Laser attachment (1064 nm): removal of dark tattoos and treatment of benign pigmented lesions.
Pulsed Light attachments (400, 500, 520, 550, 650 to 950 nm): permanent hair reduction, treatment of benign cutaneous vascular lesions including facial and leg veins, benign pigmented epidermal lesions, moderate inflammatory acne vulgaris.
Different wavelength ranges of Pulsed Light attachments are indicated for the various treatments and skin types, as indicated in the following table:
400 - 950 nm: Moderate Inflammatory Acne Vulgaris (Skin Types I, II, III, IV)
500 - 950 nm: Benign Cutaneous Vascular Lesions (Skin Types I, II)
520 - 950 nm: Benign Cutaneous Vascular Lesions (Skin Type III); Benign Pigmented Epidermal Lesions (Skin Types I, II); Permanent Hair Reduction (Skin Types I, II)
550 - 950 nm: Benign Pigmented Epidermal Lesions (Skin Types III, IV); Permanent Hair Reduction (Skin Types I, II, III)
650-950 nm: Permanent Hair Reduction (Skin Type IV)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082039: Synchro HP Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082039
Report an extraction error
Are you the manufacturer?
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