510(k) · Cleared
ClearedStrawberry, Strawberry & Cream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laser Lipo Limited · OLI Fat Reducing Low Level Laser
Cleared on Sep 6, 2013 as substantially equivalent to K111501 (Chromogenex Technologies Limited, 2012) after a 207-day review. Its family tree reaches back 16 generations to 1995. 12 later devices descend from it.
- Decided
- Sep 6, 2013
- Review
- 207 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K943450 (1995). 62 ancestors in all, the oldest K800617 (1980). 12 later devices descend from it, 4 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 2 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 1 generation backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- This deviceK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- Descendant · cites it directly · 8 of its ownK202955 Contour Light CL-100Contour Research, LLC · 2021
- Descendant · 2 generations on · 5 of its ownK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 1 of its ownK243854 Contour Light (CL-100)Contour Research, LLC · 2026
- Descendant · 3 generations on · 1 of its ownK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 4 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 3 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 2 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 1 generation backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- This deviceK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K202955Contour Light CL-100Contour Research, LLC · 2021 · cites it directly8descendants
- K232977Biophotas Celluma CONTOURBiophotas, Inc. · 2023 · 2 generations on5descendants
- K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · 3 generations on1descendant
- K243854Contour Light (CL-100)Contour Research, LLC · 2026 · 2 generations on1descendant
- K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −4 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −3 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −2 | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| −1 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| 0 (this device) | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| +1 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| +2 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
| +3 | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K243854 | Contour Light (CL-100) | Contour Research, LLC | 2026 | — |
| +3 | K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K111501 | I-Lipo SystemSummary page 2…laser system and Strawberry & Cream low level laser system is substantially equivalent in design, use and materials to the: Chromogenex Technologies Ltd 1-Lipo System -K111501 *They are made of the similar materials *They have similar indications for use that are achieved through the sa… | 2012 |
What descends from it? (12)
See all 124 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 18 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 3 of the 62 ancestors have a recall of any class.
- Of its descendants, K202955 (Contour Research, LLC, 2021) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K111501.
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. 2013, 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 Low level Laser model Strawberry and Strawberry and Cream can be used for the non-invasive temporary reduction in 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 as stated in the FDA summary.
https://510kreport.com/device/K130341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130341: Strawberry, Strawberry & Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130341
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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