510(k) · Cleared
ClearedBTL-754FF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 18, 2026 as substantially equivalent to K241270 (BTL Industries, Inc., 2025) and 6 other predicates after a 189-day review. Its family tree reaches back 27 generations to 1995.
- Decided
- Feb 18, 2026
- Review
- 189 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 27 generations to K943450 (1995). 612 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations between
- 3 generations backK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
- 2 generations backK230308 Alma HarmonyAlma Lasers, Inc. · 2023
- 1 generation backK233024 Alma HarmonyAlma Lasers, Inc. · 2024
- This deviceK252561 BTL-754FFBTL Industries, Inc. · 2026
Show all 27 generations
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 26 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 25 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 23 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 22 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 21 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 20 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 19 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 18 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 16 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 15 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 14 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 13 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 12 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 11 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 10 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 9 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 8 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 7 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 6 generations backK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- 5 generations backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- 4 generations backK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- 3 generations backK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
- 2 generations backK230308 Alma HarmonyAlma Lasers, Inc. · 2023
- 1 generation backK233024 Alma HarmonyAlma Lasers, Inc. · 2024
- This deviceK252561 BTL-754FFBTL Industries, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −26 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −25 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −23 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −22 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −21 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −20 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −19 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −18 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −16 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −15 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −14 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −13 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −12 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −11 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −10 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −9 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −8 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −7 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −6 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| −5 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| −4 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| −3 | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
| −2 | K230308 | Alma Harmony | Alma Lasers, Inc. | 2023 | — |
| −1 | K233024 | Alma Harmony | Alma Lasers, Inc. | 2024 | — |
| 0 (this device) | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 11 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 28 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 34 | 0 |
| 1999 | 30 | 0 |
| 2000 | 37 | 0 |
| 2001 | 36 | 0 |
| 2002 | 44 | 0 |
| 2003 | 50 | 0 |
| 2004 | 40 | 0 |
| 2005 | 33 | 0 |
| 2006 | 19 | 0 |
| 2007 | 21 | 0 |
| 2008 | 23 | 0 |
| 2009 | 14 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K241270 | BTL-754Summary page 7…oducts that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers: Predicate device name: BTL-754 510(k) Number: K241270 Original 510(k) Sponsor: BTL Industries, Inc. Predicate device name: Arami… | 2025 |
| * | K153229 | SuperbiumSummary page 7…Predicate device name: Aramis II Predicate device name: Superbium Dermatological Laser 510(k) Number: K153229 510(k) Number: K023734, K032260 Original 510(k) Sponsor: BIOS S.R.L Original 510(… | 2016 |
| * | K023734 | Aramis II Dermatological LaserSummary page 7…te device name: Aramis II Predicate device name: Superbium Dermatological Laser 510(k) Number: K153229 510(k) Number: K023734, K032260 Original 510(k) Sponsor: BIOS S.R.L Original 510(k) Sponsor: Quantel Medical Predicate device name: M… | 2003 |
| * | K032260 | Aramis II Dermatological LaserSummary page 7…name: Aramis II Predicate device name: Superbium Dermatological Laser 510(k) Number: K153229 510(k) Number: K023734, K032260 Original 510(k) Sponsor: BIOS S.R.L Original 510(k) Sponsor: Quantel Medical Predicate device name: MCL 31 Der… | 2003 |
| * | K150140 | MCL 31 DermablateSummary page 7…S.R.L Original 510(k) Sponsor: Quantel Medical Predicate device name: MCL 31 Dermablate Predicate device name: Alma Harmony 510(k) Number: K150140 510(k) Number: K233024 Original 510(k) Sponsor: Asclepion Laser Original 510(k) Sponso… | 2015 |
| * | K233024 | Alma HarmonySummary page 7…el Medical Predicate device name: MCL 31 Dermablate Predicate device name: Alma Harmony 510(k) Number: K150140 510(k) Number: K233024 Original 510(k) Sponsor: Asclepion Laser Original 510(k) Sponsor: Alma Lasers, Technologies GMBH… | 2024 |
| * | K210634 | MCL 31 Dermablate SystemSummary page 18…to be substantially equivalent to currently marketed predicate devices BTL-754 (K241270), Alma Harmony (K233024), Superbium (K153229), Dermablate (K150140), Dermablate (K210634), Aramis II (K023734) and Aramis II (K032260). 510(k) Summary… | 2022 |
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 31 years and passes through 11 companies; a new generation was cleared every 11 months on median.
- 29 of the 612 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. 2026, 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 BTL-754FF device with BTL-754-1 handpiece has the following indications for use: The BTL-754-1 with 2940nm is intended for use in Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of: o Acne scars o Wrinkles The BTL-754-1 with 1540nm is intended to be used for incision…
Read the full statement (290 words)
The BTL-754FF device with
BTL-754-1 handpiece has the following indications for use:
The BTL-754-1 with 2940nm is intended for use in Coagulation, vaporization, ablation or cutting of soft tissue (skin) in
Dermatology, Plastic Surgery, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
Laser skin resurfacing procedures for the treatment of:
o Acne scars
o Wrinkles
The BTL-754-1 with 1540nm is intended to be used for incision, excision, ablation, and coagulation (hemostasis) of soft
tissue. The device is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular
lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), for the treatment of periorbital and
perioral wrinkles, for the treatment of back acne.
The BTL-754-1 with combined 1540nm and 2940nm is intended for dermatological procedures requiring coagulation,
resurfacing, and ablation of soft tissue. Procedures include skin resurfacing, treatment of wrinkles and textural
irregularities.
BTL-754-4 handpiece has the following indications for use:
The BTL-754-4 with 2940nm in Fractional mode is intended for use in dermatological procedures requiring coagulation,
resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows,
fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The BTL-754-4 with 1540nm in Fractional mode is intended for use in coagulation of soft tissue, skin resurfacing
procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The BTL-754-4 with combined 1540nm and 2940nm in Fractional mode is intended for dermatological procedures
requiring coagulation, resurfacing, and ablation of soft tissue.
Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities,
dyschromia and pigmented lesions.
The BTL-754-4 with 1540nm in Macro mode is intended for use in dermatological procedures requiring skin resurfacing
and coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252561: BTL-754FF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252561
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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