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 Dec 5, 2013 as substantially equivalent to K112715 (Candela Corp., 2011) and 1 other predicate after a 231-day review. Its family tree reaches back 17 generations to 1995. 17 later devices descend from it.
- Decided
- Dec 5, 2013
- Review
- 231 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K943450 (1995). 252 ancestors in all, the oldest K800617 (1980). 17 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 2 generations backK082039 Synchro HP PlatformEl.En Electronic Engineering Spa · 2009
- 1 generation backK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- This deviceK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- Descendant · cites it directly · 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 · 2 generations on · 2 of its ownK233090 DEKA AGAIN PRO familyEl.En S.P.A. · 2023
- Descendant · 2 generations on · 2 of its ownK181486 DEKA Motus AYEl.En Electronic Engineering Spa · 2018
- Descendant · 3 generations on · 1 of its ownK211821 DEKA Motus AZEl.En Electronic Engineering Spa · 2021
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 4 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 3 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 2 generations backK082039 Synchro HP PlatformEl.En Electronic Engineering Spa · 2009
- 1 generation backK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- This deviceK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015 · cites it directly16descendants
- K192539Deka LuxeaEl.En Electronic Engineering Spa · 2019 · 2 generations on4descendants
- K233090DEKA AGAIN PRO familyEl.En S.P.A. · 2023 · 2 generations on2descendants
- K181486DEKA Motus AYEl.En Electronic Engineering Spa · 2018 · 2 generations on2descendants
- K211821DEKA Motus AZEl.En Electronic Engineering Spa · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −4 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −2 | K082039 | Synchro HP Platform | El.En Electronic Engineering Spa | 2009 | — |
| −1 | K103288 | Deka Synchro FT | El.En Electronic Engineering Spa | 2011 | — |
| 0 (this device) | K131095 | Deka Synchro Repla: Y Family of Laser Systems | El.En Electronic Engineering Spa | 2013 | — |
| +1 | 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 | — |
| +2 | K233090 | DEKA AGAIN PRO family | El.En S.P.A. | 2023 | — |
| +2 | K181486 | DEKA Motus AY | El.En Electronic Engineering Spa | 2018 | — |
| +3 | K211821 | DEKA Motus AZ | El.En Electronic Engineering Spa | 2021 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K112715 | Candela Gentlemax Family of Lasers Our reading of the summary gave K122715, FDA’s number for Stellar 150 (Resmed Germany, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Candela GentleMAX family of laser systems”. | 2011 |
| * | K103288 | Deka Synchro FTSummary page 3…DEKA Synchro Predicate Device Device Trade Repla:Y family of lasel K 103288 Name systems DEKA Synchro FT… | 2011 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150516 | Deka Synchro Repla:Y Family of Laser Systems | 2015 | 16 |
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 18 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 11 of the 252 ancestors have a recall of any class.
- Of its descendants, K150516 (El.En Electronic Engineering Spa, 2015) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K112715.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 DEKA Synchro Repla:Y family of laser systems is 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 I - VI) including tanned skin.…
Read the full statement (368 words)
The DEKA Synchro Repla:Y family of laser systems is 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 I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
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 1-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacca, 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 spats), cafe au lait macules, sebarrheic 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 handojece:
Permanent hair reduction, photocoagulation of vascular lesions, phototherniolysis 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 wavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions
500- l200nm | - | Skin Typesl,il | Skin Types L. 11
520- l200nm | | Skin TypelHI | Skin Typetll | Skin Types I I
550- l200rnn | Skin Types1, 11- | | | Skin Type 111
600- I2013mn | Skin Type Mn- | | |
650- l200nnx | Skin Type IV | -- | | Skin TyeI
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131095: 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/K131095
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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