510(k) · Cleared
ClearedBTL-754
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 Jan 30, 2025 as substantially equivalent to K142376 (Cynosure, Inc., 2014) after a 269-day review. Its family tree reaches back 18 generations to 1992. 1 later device descends from it.
- Decided
- Jan 30, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K910422 (1992). 252 ancestors in all, the oldest K820106 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 14 generations between
- 3 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 2 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 1 generation backK142376 Palomar Icon Aesthetic SystemCynosure, Inc. · 2014
- This deviceK241270 BTL-754BTL Industries, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252561 BTL-754FFBTL Industries, Inc. · 2026
Show all 18 generations
- Root · 18 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 17 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 16 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 15 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 14 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 13 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 12 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 11 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 10 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 9 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 8 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 7 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 6 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 5 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 4 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 3 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 2 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 1 generation backK142376 Palomar Icon Aesthetic SystemCynosure, Inc. · 2014
- This deviceK241270 BTL-754BTL Industries, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252561BTL-754FFBTL Industries, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −17 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −16 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −15 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −14 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −13 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −12 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −11 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −10 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −9 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −8 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −7 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −6 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −5 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −4 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −3 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −2 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −1 | K142376 | Palomar Icon Aesthetic System | Cynosure, Inc. | 2014 | — |
| 0 (this device) | K241270 | BTL-754 | BTL Industries, Inc. | 2025 | — |
| +1 | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1993 | 8 | 0 |
| 1994 | 13 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 15 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 18 | 0 |
| 2001 | 22 | 0 |
| 2002 | 27 | 0 |
| 2003 | 23 | 0 |
| 2004 | 13 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K142376 | Palomar Icon Aesthetic SystemSummary page 6…under the following 510(k) Premarket Notification numbers: Predicate device name: Palomar Icon Aesthetic System Original 510(k) Sponsor: Cynosure, Inc. 510(k) Number: K142376 Product Description The BTL-754 is a medical device containing two laser wavelengths. A laser is a device that can generate li… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252561 | BTL-754FF | 2026 | 0 |
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 33 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 252 ancestors have a recall of any class.
- Of its descendants, K252561 (BTL Industries, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142376.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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-754 device with BTL-754-4 handpiece has the following indications for use: The 2940nm Fractional handpiece 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 1540nm Fractional handpiece is intended for use in coagulation…
Read the full statement (116 words)
The BTL-754 device with BTL-754-4 handpiece has the following indications for use:
The 2940nm Fractional handpiece 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 1540nm Fractional handpiece 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 combined 1540nm and 2940nm Fractional handpiece 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241270: BTL-754.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241270
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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