510(k) · Cleared
ClearedDeka Synchro Repla:Y Family of Laser Systems
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 Apr 13, 2015 as substantially equivalent to K131095 (El.En Electronic Engineering Spa, 2013) after a 42-day review. Its family tree reaches back 18 generations to 1995. 16 later devices descend from it.
- Decided
- Apr 13, 2015
- Review
- 42 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K943450 (1995). 253 ancestors in all, the oldest K800617 (1980). 16 later devices descend from it, 6 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK082039 Synchro HP PlatformEl.En Electronic Engineering Spa · 2009
- 2 generations backK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- 1 generation backK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- This deviceK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
- Descendant · cites it directly · 4 of its ownK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
- Descendant · cites it directly · 2 of its ownK233090 DEKA AGAIN PRO familyEl.En S.P.A. · 2023
- Descendant · cites it directly · 2 of its ownK181486 DEKA Motus AYEl.En Electronic Engineering Spa · 2018
- Descendant · 2 generations on · 1 of its ownK211821 DEKA Motus AZEl.En Electronic Engineering Spa · 2021
- Descendant · cites it directly · 1 of its ownK193426 Elite iQCynosure, LLC · 2020
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 5 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 4 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 3 generations backK082039 Synchro HP PlatformEl.En Electronic Engineering Spa · 2009
- 2 generations backK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- 1 generation backK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- This deviceK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K192539Deka LuxeaEl.En Electronic Engineering Spa · 2019 · cites it directly4descendants
- K233090DEKA AGAIN PRO familyEl.En S.P.A. · 2023 · cites it directly2descendants
- K181486DEKA Motus AYEl.En Electronic Engineering Spa · 2018 · cites it directly2descendants
- K211821DEKA Motus AZEl.En Electronic Engineering Spa · 2021 · 2 generations on1descendant
- K193426Elite iQCynosure, LLC · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −5 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −4 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −3 | K082039 | Synchro HP Platform | El.En Electronic Engineering Spa | 2009 | — |
| −2 | K103288 | Deka Synchro FT | El.En Electronic Engineering Spa | 2011 | — |
| −1 | K131095 | Deka Synchro Repla: Y Family of Laser Systems | El.En Electronic Engineering Spa | 2013 | — |
| 0 (this device) | K150516 | Deka Synchro Repla:Y Family of Laser Systems | El.En Electronic Engineering Spa | 2015 | — |
| +1 | K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019 | — |
| +1 | K233090 | DEKA AGAIN PRO family | El.En S.P.A. | 2023 | — |
| +1 | K181486 | DEKA Motus AY | El.En Electronic Engineering Spa | 2018 | — |
| +2 | K211821 | DEKA Motus AZ | El.En Electronic Engineering Spa | 2021 | — |
| +1 | K193426 | Elite iQ | Cynosure, LLC | 2020 | — |
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 | 23 | 0 |
| 2001 | 24 | 0 |
| 2002 | 30 | 0 |
| 2003 | 25 | 0 |
| 2004 | 13 | 0 |
| 2005 | 8 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K131095 | Deka Synchro Repla: Y Family of Laser SystemsSummary page 5…or use in General and Plastic Surgery and in Dermatology (GEX) Classification Number: 21 CFR 878.4810 Equivalent Devices: DEKA Synchro Repla:Y family of laser systems (K131095). Device Description: The Deka Synchro Repla:Y family of lasers is a platform which can be equipped with two separate solid stat… | 2013 |
What descends from it? (16)
See all 166 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?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 11 of the 253 ancestors have a recall of any class.
- Of its descendants, K192539 (El.En Electronic Engineering Spa, 2019) has gone furthest, with 4 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. 2015, 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?
755mn laser: Temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick 1 — VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles.…
Read the full statement (342 words)
755mn laser:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
On all skin types (Fitzpatrick 1 — VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangicctasias).
1064nm laser:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots). solar lentigos (sun spots), cafe au lait macules, scborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Pulsed light FT handpiece:
Permanent hair reduction, photocoagulation of vascular lesions. photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:
Pulsed light Hair reduction Vascular lesions Blood vessels Pigmented lesions
Wavelength range
500-1200nm - Skin Types I, 11 Skin Types I, 11 -
520-1200nm - Skin Type I Skin Type I Skin Types LTI
550-1200nm Skin Types I, 11 - - Skin Type 11l
600-1200nm Skin Type I11 - - -
650-1200nm Skin Type IV - - Skin Type IV
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150516: Deka Synchro Repla:Y Family of Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150516
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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