510(k) · Cleared
ClearedBTL-9000; BTL-9000 Radiofrequency Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Btl Industries, Ltd. · OLI Fat Reducing Low Level Laser
Cleared on Sep 10, 2014 as substantially equivalent to K130341 (Laser Lipo Limited, 2013) after a 253-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- Sep 10, 2014
- Review
- 253 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 63 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 2 generations backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- 1 generation backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- This deviceK134040 BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd. · 2014
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 backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 5 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 4 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 3 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 2 generations backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- 1 generation backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- This deviceK134040 BTL-9000; BTL-9000 Radiofrequency ModuleBtl Industries, Ltd. · 2014
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 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −5 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −4 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −3 | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| −2 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| −1 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| 0 (this device) | K134040 | BTL-9000; BTL-9000 Radiofrequency Module | Btl Industries, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 OLI? 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 OLI device
- #1 K232977 Biophotas Celluma CONTOURscore 23.5 · 18 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 |
|---|---|---|---|
| * | K130341 | Strawberry, Strawberry & CreamSummary page 5…Laser System Company BTL Industries, Ltd. Laser Lipo, Ltd. name 510(k) K134040 K130341 reference Device Device consists of an electrically Device consists of an electrically description powered c… | 2013 |
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 19 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- 3 of the 63 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130341.
How does its category compare?
All OLI devicesOLI Fat Reducing Low Level Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OLI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLI
No recall names OLI since 2007.
Adverse event reports per year · OLI
2in 2023
MAUDE reports naming product code OLI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 4 | 93 | 0 | 0 |
| 2013 | 3 | 101 | 0 | 4 |
| 2014 | 3 | 159 | 0 | 0 |
| 2015 | 3 | 90 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 3 | 121 | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 90 | 0 | 0 |
| 2026 | 3 | 89 | 0 | — |
What is it indicated for?
The BTL-9000 device is a low level laser system that can be used for the non-invasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
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/K134040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K134040: BTL-9000; BTL-9000 Radiofrequency Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K134040
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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