510(k) · Cleared
ClearedI-Lipo System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chromogenex Technologies Limited · OLI Fat Reducing Low Level Laser
Cleared on Mar 23, 2012 as substantially equivalent to K101366 (Chromogenex Technologies, Ltd., 2010) and 1 other predicate after a 297-day review. Its family tree reaches back 15 generations to 1995. 15 later devices descend from it.
- Decided
- Mar 23, 2012
- Review
- 297 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K943450 (1995). 61 ancestors in all, the oldest K800617 (1980). 15 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 2 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 1 generation backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- This deviceK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- Descendant · cites it directly · 12 of its ownK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- Descendant · 2 generations on · 8 of its ownK202955 Contour Light CL-100Contour Research, LLC · 2021
- Descendant · 3 generations on · 5 of its ownK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK143741 Lipofina Laser SystemYolo Medical, Inc. · 2015
- Descendant · 4 generations on · 1 of its ownK260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 3 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 2 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 1 generation backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- This deviceK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K130341Strawberry, Strawberry & CreamLaser Lipo Limited · 2013 · cites it directly12descendants
- K202955Contour Light CL-100Contour Research, LLC · 2021 · 2 generations on8descendants
- K232977Biophotas Celluma CONTOURBiophotas, Inc. · 2023 · 3 generations on5descendants
- K143741Lipofina Laser SystemYolo Medical, Inc. · 2015 · cites it directly3descendants
- K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −3 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −2 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −1 | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| 0 (this device) | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| +1 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| +2 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| +3 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
| +1 | K143741 | Lipofina Laser System | Yolo Medical, Inc. | 2015 | — |
| +4 | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Summary page 1…Low Level Laser System Proprietary name i~lipoTM System C. Predicate Devices: Chromogenex Technologies Limited - ilipo Ultra System - K1 01366 Erchonia Medical Inc - Erchonia ML Scanner - K082609 D. Device Description: The j~ljp0 TM System consists of a main unit, and a… | 2010 |
| * | DEN090008 | Erchonia ML Scanner (MLS) Our reading of the summary gave K082609, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090008, Erchonia ML Scanner (MLS) (Erchonia Medical), granted Aug 24, 2010; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2010 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 3 of the 61 ancestors have a recall of any class.
- Of its descendants, K130341 (Laser Lipo Limited, 2013) has gone furthest, with 12 descendants of its own.
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. 2012, 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 j~ljp0 TM Low Level Laser System is indicated for Non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111501: I-Lipo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111501
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