510(k) · Cleared
ClearedMOTUS PRO Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En S.P.A. · GEX Powered Laser Surgical Instrument
Cleared on Jun 21, 2024 as substantially equivalent to K211821 (El.En Electronic Engineering Spa, 2021) after a 29-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Jun 21, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K943450 (1995). 256 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
- 2 generations backK181486 DEKA Motus AYEl.En Electronic Engineering Spa · 2018
- 1 generation backK211821 DEKA Motus AZEl.En Electronic Engineering Spa · 2021
- This deviceK241459 MOTUS PRO FamilyEl.En S.P.A. · 2024
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 8 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 7 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 6 generations backK082039 Synchro HP PlatformEl.En Electronic Engineering Spa · 2009
- 5 generations backK103288 Deka Synchro FTEl.En Electronic Engineering Spa · 2011
- 4 generations backK131095 Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2013
- 3 generations backK150516 Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 2015
- 2 generations backK181486 DEKA Motus AYEl.En Electronic Engineering Spa · 2018
- 1 generation backK211821 DEKA Motus AZEl.En Electronic Engineering Spa · 2021
- This deviceK241459 MOTUS PRO FamilyEl.En S.P.A. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −8 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −7 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −6 | K082039 | Synchro HP Platform | El.En Electronic Engineering Spa | 2009 | — |
| −5 | K103288 | Deka Synchro FT | El.En Electronic Engineering Spa | 2011 | — |
| −4 | 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 | K181486 | DEKA Motus AY | El.En Electronic Engineering Spa | 2018 | — |
| −1 | K211821 | DEKA Motus AZ | El.En Electronic Engineering Spa | 2021 | — |
| 0 (this device) | K241459 | MOTUS PRO Family | El.En S.P.A. | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K211821 | DEKA Motus AZSummary page 5…cal Instrument for use in General and Plastic and in Dermatology Regulation Class: Class II Product Code: GEX Predicate Devices: Primary predicate: DEKA Motus AZ (K211821) Reference predicate: DEKA AGAIN PRO family (K233090) Device Description: MOTUS PRO family is a medical laser family equipp… | 2021 |
| † | K233090 | DEKA AGAIN PRO family | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 256 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
MOTUS PRO family is a medical laser family intended for: Alexandrite 755nm laser source: - 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) included tanned…
Read the full statement (262 words)
MOTUS PRO family is a medical laser family intended for:
Alexandrite 755nm laser source:
- 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) included tanned skin.
- Treatment of benign pigmented lesions.
- Photocoagulation of benign dermatological vascular lesions (such as port wine stains,
hemangiomas, telangiectasias).
Nd:YAG 1064nm laser source:
- Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of
PFB. The laser 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, teleangiectasias, 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), café au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and
plaques.
- The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions
that would potentially benefit from aggressive treatment, and for patient with lesions that have not
responded to other 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.
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/K241459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241459: MOTUS PRO Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241459
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