510(k) · Cleared
Clearedinvisa-RED ELITE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
IR Technology, LLC · OLI Fat Reducing Low Level Laser
Cleared on Aug 19, 2020 as substantially equivalent to K130341 (Laser Lipo Limited, 2013) and 3 other predicates after a 363-day review. Its family tree reaches back 17 generations to 1995. 1 later device descends from it.
- Decided
- Aug 19, 2020
- Review
- 363 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K943450 (1995). 114 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 2 generations backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- 1 generation backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- This deviceK192275 invisa-RED ELITEIR Technology, LLC · 2020
- Descendant · cites it directly · 0 of its ownK213534 PHantom TrilogyResurgeonz, LLC · 2022
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 5 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 4 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 3 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 2 generations backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- 1 generation backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- This deviceK192275 invisa-RED ELITEIR Technology, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K213534PHantom TrilogyResurgeonz, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −5 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −4 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −3 | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| −2 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| −1 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| 0 (this device) | K192275 | invisa-RED ELITE | IR Technology, LLC | 2020 | — |
| +1 | K213534 | PHantom Trilogy | Resurgeonz, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 15 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K130341 | Strawberry, Strawberry & CreamSummary page 5…roduct Code: OLI Regulation Number: 21 CFR 878.5400 Review Panel: Division of Surgical Devices 5. Predicate Device Identification Primary Predicate: 510(k) Number: K130341 Product Name: Strawberry, Strawberry & Cream Manufacturer: LASER LIPO LIMITED Secondary Predicates: 510(k) Number: K123237 Prod… | 2013 |
| * | K123237 | Zerona 2.0 LaserSummary page 5…fication Primary Predicate: 510(k) Number: K130341 Product Name: Strawberry, Strawberry & Cream Manufacturer: LASER LIPO LIMITED Secondary Predicates: 510(k) Number: K123237 Product Name: Zerona 2.0 Laser Manufacturer: ERCHONIA CORPORATION 510(k) Number: K143741 Product Name: Lipofina Laser System Man… | 2013 |
| * | K143741 | Lipofina Laser SystemSummary page 5…& Cream Manufacturer: LASER LIPO LIMITED Secondary Predicates: 510(k) Number: K123237 Product Name: Zerona 2.0 Laser Manufacturer: ERCHONIA CORPORATION 510(k) Number: K143741 Product Name: Lipofina Laser System Manufacturer: YOLO Medical Inc. 510(k) Number: K160880 Product Name: Photonica Professional… | 2015 |
| * | K160880 | Photonica ProfessionalSummary page 5…uct Name: Zerona 2.0 Laser Manufacturer: ERCHONIA CORPORATION 510(k) Number: K143741 Product Name: Lipofina Laser System Manufacturer: YOLO Medical Inc. 510(k) Number: K160880 Product Name: Photonica Professional Manufacturer: WARD PHOTONICS LLC 6380 Bells Ferry Rd Acworth… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213534 | PHantom Trilogy | 2022 | 0 |
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 9 companies; a new generation was cleared every 9 months on median.
- 4 of the 114 ancestors have a recall of any class.
- Of its descendants, K213534 (Resurgeonz, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K130341.
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?
The InvisaRED™ Technology ELITE is indicated for use as a non-invasive dermatological aesthetic treatment for the temporary reduction of the circumference of waist, hips, and thighs through the process of photobiomodulation, affecting adipocyte cells within the adipose layer for the release of lipids from these cells.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192275: invisa-RED ELITE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192275
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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