510(k) · Cleared
ClearedBiophotas Celluma CONTOUR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biophotas, Inc. · OLI Fat Reducing Low Level Laser
Cleared on Nov 21, 2023 as substantially equivalent to K202955 (Contour Research, LLC, 2021) and 2 other predicates after a 61-day review. Its family tree reaches back 18 generations to 1995. 5 later devices descend from it.
- Decided
- Nov 21, 2023
- Review
- 61 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K943450 (1995). 171 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 4 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- 2 generations backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- 1 generation backK202955 Contour Light CL-100Contour Research, LLC · 2021
- This deviceK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · cites it directly · 1 of its ownK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK260715 CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK260688 Sculpt LED Belt…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251781 Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 6 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 5 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 4 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 3 generations backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- 2 generations backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- 1 generation backK202955 Contour Light CL-100Contour Research, LLC · 2021
- This deviceK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly1descendant
- K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · cites it directly1descendant
- K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026 · 2 generations on0descendants
- K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
- K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −6 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −5 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −4 | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| −3 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| −2 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| −1 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| 0 (this device) | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
| +1 | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +1 | K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +2 | K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026 | — |
| +1 | K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +1 | K251781 | Kala Mini 2.0 (Kala-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 14 | 0 |
| 1997 | 17 | 0 |
| 1998 | 10 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 8 | 0 |
| 2002 | 15 | 0 |
| 2003 | 10 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 3 | 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 K260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )score 19.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K202955 | Contour Light CL-100Summary page 5…Class II Product Code: OLI, ILY, OHS Classification Panel: General & Plastic Surgery Predicate device(s) Contour Light CL-100 device (K202955) Biophotas Celluma 3 (K171323). Biophotas Celluma (K131113). Date Prep… | 2021 |
| * | K171323 | Biophotas CELLUMA3Summary page 5…ssification Panel: General & Plastic Surgery Predicate device(s) Contour Light CL-100 device (K202955) Biophotas Celluma 3 (K171323). Biophotas Celluma (K131113). Date Prepared: November 14th, 2023. Device Description The BioPhot… | 2017 |
| * | K131113 | Biophotas CellumaSummary page 5…cate device(s) Contour Light CL-100 device (K202955) Biophotas Celluma 3 (K171323). Biophotas Celluma (K131113). Date Prepared: November 14th, 2023. Device Description The BioPhotas Celluma CONTOUR is a Light emitting diode (LED) system… | 2014 |
What descends from it? (5)
4 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 28 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 171 ancestors have a recall of any class.
- Of its descendants, K260129 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K202955.
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. 2023, 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 BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
The BIOPHOTAS Celluma CONTOUR is intended to deliver heat in the near infra-red spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
The BioPhotas Celluma CONTOUR is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232977 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232977: Biophotas Celluma CONTOUR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232977
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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