510(k) · Cleared
ClearedPhotonica Professional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ward Photonics, LLC · OLI Fat Reducing Low Level Laser
Cleared on Sep 23, 2016 as substantially equivalent to DEN090008 (Erchonia Medical, 2010) and 1 other predicate after a 177-day review. Its family tree reaches back 10 generations to 1995. 6 later devices descend from it.
- Decided
- Sep 23, 2016
- Review
- 177 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K943450 (1995). 85 ancestors in all, the oldest K800617 (1980). 6 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK150336 Photonica ProfessionalWard Photonics, LLC · 2015
- This deviceK160880 Photonica ProfessionalWard Photonics, LLC · 2016
- Descendant · cites it directly · 2 of its ownK180338 CellulizeWard Photonics, LLC · 2018
- Descendant · cites it directly · 1 of its ownK192275 invisa-RED ELITEIR Technology, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK213534 PHantom TrilogyResurgeonz, LLC · 2022
- Descendant · cites it directly · 0 of its ownK210535 UltraLight LED SystemRohrer Aesthetics, LLC · 2021
- Descendant · cites it directly · 0 of its ownK202361 UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC · 2020
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 2 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 1 generation backK150336 Photonica ProfessionalWard Photonics, LLC · 2015
- This deviceK160880 Photonica ProfessionalWard Photonics, LLC · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180338CellulizeWard Photonics, LLC · 2018 · cites it directly2descendants
- K192275invisa-RED ELITEIR Technology, LLC · 2020 · cites it directly1descendant
- K213534PHantom TrilogyResurgeonz, LLC · 2022 · 2 generations on0descendants
- K210535UltraLight LED SystemRohrer Aesthetics, LLC · 2021 · cites it directly0descendants
- K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −2 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −1 | K150336 | Photonica Professional | Ward Photonics, LLC | 2015 | — |
| 0 (this device) | K160880 | Photonica Professional | Ward Photonics, LLC | 2016 | — |
| +1 | K180338 | Cellulize | Ward Photonics, LLC | 2018 | — |
| +1 | K192275 | invisa-RED ELITE | IR Technology, LLC | 2020 | — |
| +2 | K213534 | PHantom Trilogy | Resurgeonz, LLC | 2022 | — |
| +1 | K210535 | UltraLight LED System | Rohrer Aesthetics, LLC | 2021 | — |
| +1 | K202361 | UltraSlim Digital, UltraSmooth Digital | Ward Photonics, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | 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 |
| * | K150336 | Photonica ProfessionalSummary page 4…tially equivalent to the ERCHONIA ML SCANNER manufactured by Erchonia and subject of K082609 (DEN090008). PHOTONICA PROFESSIONAL (K150336) The Photonica Professional is substantially equivalent to itself, being previously cleared (GEX) for… | 2015 |
What descends from it? (6)
5 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 21 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 85 ancestors have a recall of any class.
- Of its descendants, K180338 (Ward Photonics, LLC, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate DEN090008.
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. 2016, 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?
Photonica Professional is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. Photonica Professional is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160880: Photonica Professional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160880
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