510(k) · Cleared
ClearedOR-Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yperion Technology · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Oct 7, 2009 as substantially equivalent to K030480 (A&M Technology, 2003) and 1 other predicate after a 202-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Oct 7, 2009
- Review
- 202 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K910422 (1992). 64 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- 2 generations backK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- 1 generation backK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
- This deviceK090724 OR-LightYperion Technology · 2009
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- 4 generations backK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- 3 generations backK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- 2 generations backK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- 1 generation backK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
- This deviceK090724 OR-LightYperion Technology · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| −4 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
| −3 | K043255 | Ellipse Light SPT | Danish Dermatologic Development A/S | 2005 | — |
| −2 | K052688 | Ellipse Flex PPT, Model 9ESF7255 | Danish Dermatologic Development A/S | 2005 | — |
| −1 | K060516 | Ellipse 12PL, Model 9ESL7228 | Danish Dermatologic Development A/S | 2006 | — |
| 0 (this device) | K090724 | OR-Light | Yperion Technology | 2009 | — |
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 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 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 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? (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 |
|---|---|---|---|
| * | K030480 | L600 Hair RemovalSummary page 1…in dermatology Product code: GEX Regulation Number: 878 4810 Predicated device Yperion Technology: L600®; K030480 Danish Dermatologic Developpement (as DDD): Ellipse I2PL ; K060516 System Description The Or-Light® is a non-coherent light bas… | 2003 |
| * | K060516 | Ellipse 12PL, Model 9ESL7228Summary page 1…de: GEX Regulation Number: 878 4810 Predicated device Yperion Technology: L600®; K030480 Danish Dermatologic Developpement (as DDD): Ellipse I2PL ; K060516 System Description The Or-Light® is a non-coherent light based device intended to carry out dermatologic and aesthetic care on… | 2006 |
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 17 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 64 ancestors have a recall of any class.
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. 2009, 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 Or-Light® is a non-coherent light-based device intended to carry out dermatologic and aesthetic care. It is meant to be handled by competent professionals trained in intense pulsed light technology.
Two different applicators can be used on the Or-Light® device.
The HR applicator (610-1000 nm) is indicated for:
Hair Removal for skintype I to IV
The SR applicator (400-1000 nm) is indicated for
Benign pigmentary lesions for skintype I to III
Benign vascular lesions for skintype I to III
Inflammatory acne treatment for skintype I to III
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090724: OR-Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090724
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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