510(k) · Cleared
ClearedUltraSlim Digital, UltraSmooth Digital
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 Dec 18, 2020 as substantially equivalent to K160880 (Ward Photonics, LLC, 2016) and 2 other predicates after a 121-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Dec 18, 2020
- Review
- 121 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K943450 (1995). 88 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK150336 Photonica ProfessionalWard Photonics, LLC · 2015
- 2 generations backK160880 Photonica ProfessionalWard Photonics, LLC · 2016
- 1 generation backK180338 CellulizeWard Photonics, LLC · 2018
- This deviceK202361 UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC · 2020
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 5 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 4 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 3 generations backK150336 Photonica ProfessionalWard Photonics, LLC · 2015
- 2 generations backK160880 Photonica ProfessionalWard Photonics, LLC · 2016
- 1 generation backK180338 CellulizeWard Photonics, LLC · 2018
- This deviceK202361 UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −6 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −5 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −4 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −3 | K150336 | Photonica Professional | Ward Photonics, LLC | 2015 | — |
| −2 | K160880 | Photonica Professional | Ward Photonics, LLC | 2016 | — |
| −1 | K180338 | Cellulize | Ward Photonics, LLC | 2018 | — |
| 0 (this device) | 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 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K160880 | Photonica ProfessionalSummary page 4…t Photonica Professional Cellullize UltraSlim® UltraSmooth® Trade/Proprietary OLI (K160880) OLI (K180338) Digital Digital Name: GEX (K150336) Common/Usual Fat Re… | 2016 |
| * | K150336 | Photonica ProfessionalSummary page 4…ize UltraSlim® UltraSmooth® Trade/Proprietary OLI (K160880) OLI (K180338) Digital Digital Name: GEX (K150336) Common/Usual Fat Reducing Fat Reducing Fat Reducing Low Fat Reducing Low Name: Low… | 2015 |
| * | K180338 | CellulizeSummary page 4…Photonica Professional Cellullize UltraSlim® UltraSmooth® Trade/Proprietary OLI (K160880) OLI (K180338) Digital Digital Name: GEX (K150336) Common/Usual Fat Reducing Fat Red… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 88 ancestors have a recall of any class.
- 4 other devices also cite its predicate K160880.
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. 2020, 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?
UltraSlim DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
UltraSlim DIGITAL is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.
UltraSmooth DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
The Massager component is indicated for the temporary reduction in the appearance of cellulite.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202361: UltraSlim Digital, UltraSmooth Digital.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202361
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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