510(k) · Cleared
ClearedUltraLight LED System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rohrer Aesthetics, LLC · GEX Powered Laser Surgical Instrument
Cleared on May 24, 2021 as substantially equivalent to K180338 (Ward Photonics, LLC, 2018) and 2 other predicates after an 89-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- May 24, 2021
- Review
- 89 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K943450 (1995). 90 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 deviceK210535 UltraLight LED SystemRohrer Aesthetics, LLC · 2021
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 deviceK210535 UltraLight LED SystemRohrer Aesthetics, LLC · 2021
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) | K210535 | UltraLight LED System | Rohrer Aesthetics, LLC | 2021 | — |
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 | 3 | 0 |
| 2003 | 1 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K180338 | CellulizeSummary page 4…w Level Laser System for Aesthetic Use Regulation Number: 21 CFR 878.5400 Product Code: OLI Predicate Devices: K180338 (Cellulize), K160880 (Photonica Professional), and K030883 (Omnilux Blue) Regulatory Class:… | 2018 |
| * | K160880 | Photonica ProfessionalSummary page 4…for Aesthetic Use Regulation Number: 21 CFR 878.5400 Product Code: OLI Predicate Devices: K180338 (Cellulize), K160880 (Photonica Professional), and K030883 (Omnilux Blue) Regulatory Class: Cla… | 2016 |
| * | K030883 | Omnilux BlueSummary page 4…oduct Code: OLI Predicate Devices: K180338 (Cellulize), K160880 (Photonica Professional), and K030883 (Omnilux Blue) Regulatory Class: Class II Device Description: The UltraLight LED System is a… | 2003 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 90 ancestors have a recall of any class.
- 1 other device also cites its predicate K180338.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
LED red light: The UltraLight “red light” is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The UltraLight “red light” is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.
LED blue light: The UltraLight “blue light” is indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
LED green light: The Ultralight “green Light” is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
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/K210535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210535: UltraLight LED System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210535
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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