510(k) · Cleared
ClearedI-Lipo, Models A00-1238 (230V), A00-1239 (120V)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chromogenex Technologies, Ltd. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Sep 17, 2010 as substantially equivalent to K061603 (Biocellulase, Inc., 2006) and 1 other predicate after a 123-day review. Its family tree reaches back 14 generations to 1995. 16 later devices descend from it.
- Decided
- Sep 17, 2010
- Review
- 123 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 59 ancestors in all, the oldest K800617 (1980). 16 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 2 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 1 generation backK061603 SmoothshapesBiocellulase, Inc. · 2006
- This deviceK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- Descendant · cites it directly · 15 of its ownK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- Descendant · 2 generations on · 12 of its ownK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- Descendant · 3 generations on · 8 of its ownK202955 Contour Light CL-100Contour Research, LLC · 2021
- Descendant · 4 generations on · 5 of its ownK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK143741 Lipofina Laser SystemYolo Medical, Inc. · 2015
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 2 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 1 generation backK061603 SmoothshapesBiocellulase, Inc. · 2006
- This deviceK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K111501I-Lipo SystemChromogenex Technologies Limited · 2012 · cites it directly15descendants
- K130341Strawberry, Strawberry & CreamLaser Lipo Limited · 2013 · 2 generations on12descendants
- K202955Contour Light CL-100Contour Research, LLC · 2021 · 3 generations on8descendants
- K232977Biophotas Celluma CONTOURBiophotas, Inc. · 2023 · 4 generations on5descendants
- K143741Lipofina Laser SystemYolo Medical, Inc. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −2 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −1 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| 0 (this device) | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| +1 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| +2 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| +3 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| +4 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
| +2 | K143741 | Lipofina Laser System | Yolo Medical, Inc. | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 NUV? 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 NUV device
- #1 K261582 Vacuum Roller RF Slimming Device for Medical…score 16.7 · 17 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 |
|---|---|---|---|
| * | K061603 | SmoothshapesSummary page 1…ting Common/usual name Massager /shaper Proprietary name i~lipoTM Ultra System C. Predicate Devices: Biocellulase Smoothshapes - K061603 Meridian Co. Ltd Lapex BCS - K081 962 0. Device Description: The ilipoTM Ultra System consists of a main unit, and applied part… | 2006 |
| * | K081962 | Lapex BCSSummary page 1…Massager /shaper Proprietary name i~lipoTM Ultra System C. Predicate Devices: Biocellulase Smoothshapes - K061603 Meridian Co. Ltd Lapex BCS - K081 962 0. Device Description: The ilipoTM Ultra System consists of a main unit, and applied parts (massage head with rollers and vario… | 2008 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111501 | I-Lipo System | 2012 | 15 |
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 15 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 3 of the 59 ancestors have a recall of any class.
- Of its descendants, K111501 (Chromogenex Technologies Limited, 2012) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K061603.
How does its category compare?
All NUV devicesNUV Massager, Vacuum, Light Induced Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NUV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NUV
99in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUV
No recall names NUV since 2007.
Adverse event reports per year · NUV
1in 2020
MAUDE reports naming product code NUV, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 99 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The i~lipoTM Ultra - Vacuum Massage System - is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
The i~lipoTM Ultra -Treatment Pads and Probes - are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101366 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101366: I-Lipo, Models A00-1238 (230V), A00-1239 (120V).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101366
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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