510(k) · Cleared
ClearedLucent : IPL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luvo Medical Technologies, Inc. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Mar 5, 2020 as substantially equivalent to K072564 (Alma Lasers, Ltd., 2008) and 1 other predicate after a 122-day review. Its family tree reaches back 19 generations to 1992. 3 later devices descend from it.
- Decided
- Mar 5, 2020
- Review
- 122 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K910422 (1992). 342 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 15 generations between
- 3 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 2 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 1 generation backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- This deviceK193072 Lucent : IPLLuvo Medical Technologies, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK203728 DarwinLuvo Medical Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK240314 Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK212607 DarwinLuvo Medical Technologies, Inc. · 2021
Show all 19 generations
- Root · 19 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 18 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 17 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 16 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 15 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 14 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 13 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 12 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 11 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 10 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 9 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 8 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 7 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 6 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 5 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 4 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 3 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 2 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 1 generation backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- This deviceK193072 Lucent : IPLLuvo Medical Technologies, Inc. · 2020
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 |
|---|---|---|---|---|---|
| −19 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −18 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −17 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −16 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −15 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −14 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −13 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −12 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −11 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −10 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −9 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −8 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −7 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −6 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −5 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −4 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −3 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −2 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −1 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| 0 (this device) | K193072 | Lucent : IPL | Luvo Medical Technologies, Inc. | 2020 | — |
| +1 | K203728 | Darwin | Luvo Medical Technologies, Inc. | 2021 | — |
| +1 | K240314 | Mula (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | 2024 | — |
| +2 | K212607 | Darwin | Luvo Medical Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 16 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 24 | 0 |
| 1998 | 21 | 0 |
| 1999 | 13 | 0 |
| 2000 | 26 | 0 |
| 2001 | 27 | 0 |
| 2002 | 35 | 0 |
| 2003 | 33 | 0 |
| 2004 | 18 | 0 |
| 2005 | 14 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2024 | 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 18.2 · 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 |
|---|---|---|---|
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 5…: Alma Harmony XL Multi-Application Platform / Secondary Predicate: Lumenis M22 System 510(K) number: K072564/ K142860 Regulatory Class: Class II Prescription Use Description of the Lucent : IPL: The LUVO Med… | 2008 |
| * | K142860 | Lumenis M22 SystemSummary page 5…armony XL Multi-Application Platform / Secondary Predicate: Lumenis M22 System 510(K) number: K072564/ K142860 Regulatory Class: Class II Prescription Use Description of the Lucent : IPL: The LUVO Medical Tech… | 2015 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 342 ancestors have a recall of any class.
- Of its descendants, K203728 (Luvo Medical Technologies, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 19 other devices also cite its predicate K072564.
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. 2020, 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 Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Indication for Use for the 430-980nm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular…
Read the full statement (400 words)
The Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general
and plastic surgery, and dermatology.
Indication for Use for the 430-980nm wavelength
• Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
• For use on Fitzpatrick skin types (I-V)
Indication for use for the 515-980nm wavelength
• Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
• For use on Fitzpatrick skin types (I-V)
Indication for use for the 560-980nm wavelength
• Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
• The removal of unwanted hair to effect stable long-term or permanent hair reduction
• For use on Fitzpatrick skin types (I-V)
Indication for use for the 585-980nm wavelength
• Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
• The removal of unwanted hair to effect stable long-term or permanent hair reduction
• For use on Fitzpatrick skin types (I-V)
Indication for use for the 640-980nm wavelength
• Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
• The removal of unwanted hair to effect stable long-term or permanent hair reduction
• For use on Fitzpatrick skin types (I-V)
Indication for use for the 700-980nm wavelength
• The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime
• For use on Fitzpatrick skin types (I-V)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193072 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193072: Lucent : IPL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193072
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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