510(k) · Cleared
ClearedInmode SR Ipl Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inmode MD, Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Apr 2, 2013 as substantially equivalent to K032460 (Sciton, Inc, 2003) after a 109-day review. Its family tree reaches back 8 generations to 1992. 3 later devices descend from it.
- Decided
- Apr 2, 2013
- Review
- 109 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K910422 (1992). 64 ancestors in all, the oldest K892514 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 3 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 2 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 1 generation backK032460 Profile BBL SystemSciton, Inc · 2003
- This deviceK123860 Inmode SR Ipl DeviceInmode MD, Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK221571 InMode Multi-systemInMode, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK251632 Optimas MAX SystemInMode, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK252215 InbellaMAX SystemInbella Medical, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −2 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −1 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| 0 (this device) | K123860 | Inmode SR Ipl Device | Inmode MD, Ltd. | 2013 | — |
| +1 | K221571 | InMode Multi-system | InMode, Ltd. | 2022 | — |
| +2 | K251632 | Optimas MAX System | InMode, Ltd. | 2025 | — |
| +3 | K252215 | InbellaMAX System | Inbella Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.1 · 27 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K032460 | Profile BBL SystemSummary page 1…quivalent to the following predicate devices. Manufacturer Device 510(k) No. Sciton Profile BBL K032460 Device Description: The InMode SR IPL device is designed to deliver optical energy to the skin via a pre-cooled s… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221571 | InMode Multi-system | 2022 | 2 |
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 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 64 ancestors has a recall of any class.
- Of its descendants, K221571 (InMode, Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K032460.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The InMode SR IPL Device wavelengths (515-1 200nm) are indicated for use for the following treatments:
The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpignientation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123860: Inmode SR Ipl Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123860
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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