510(k) · Cleared
ClearedLumenis One Family of Systems; Lumenis One.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jul 6, 2006 as substantially equivalent to K020839 (Lumenis, Inc., 2002) and 9 other predicates after a 135-day review. Its family tree reaches back 13 generations to 1995. 297 later devices descend from it.
- Decided
- Jul 6, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 13 generations to K943450 (1995). 120 ancestors in all, the oldest K800617 (1980). 297 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 1 generation backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- This deviceK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 87 of its ownK121346 Picosure WorkstationCynosure, Inc. · 2012
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 8 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 7 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 6 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 5 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 1 generation backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- This deviceK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
Showing 5 of 297 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 297 · See all- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 3 generations on92descendants
- K121346Picosure WorkstationCynosure, Inc. · 2012 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −8 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −7 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −6 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −5 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −2 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −1 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| 0 (this device) | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| +4 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
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 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 15 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 12 | 0 |
| 2015 | 14 | 0 |
| 2016 | 19 | 0 |
| 2017 | 18 | 0 |
| 2018 | 18 | 0 |
| 2019 | 11 | 0 |
| 2020 | 23 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 21 | 0 |
| 2024 | 34 | 0 |
| 2025 | 36 | 0 |
| 2026 | 24 | 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? (10)
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 |
|---|---|---|---|
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…ser Powered Surgical Instrument (and Accessories) HII. Predicate Devices * Lumenis Family of Intense Pulsed-Light (IP) and IPLANd:YAG Laser Systems (K020839, K(024093, K(030342, K030527); * LightSheer Pulsed Diode Array Laser System (K(973324, K(974346, 1K982940, K(0… | 2002 |
| * | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Summary page 3…ystems share the same intended uses as the predicate devices-the Lumenis Family of Intense Pulsed-Light (IPL) and IP.L/Nd:YAG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, IC074346, IC982940, K001746, K003614), and… | 2003 |
| * | K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsSummary page 3…are the same intended uses as the predicate devices-the Lumenis Family of Intense Pulsed-Light (IPL) and IP.L/Nd:YAG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, IC074346, IC982940, K001746, K003614), and the… | 2003 |
| * | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsSummary page 1…nt (and Accessories) HII. Predicate Devices * Lumenis Family of Intense Pulsed-Light (IP) and IPLANd:YAG Laser Systems (K020839, K(024093, K(030342, K030527); * LightSheer Pulsed Diode Array Laser System (K(973324, K(974346, 1K982940, K(001746, K(003614); * A… | 2003 |
| * | K973324 | Starlight Pulsed Diode Array Laser SystemSummary page 3…ily of Intense Pulsed-Light (IPL) and IP.L/Nd:YAG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, IC074346, IC982940, K001746, K003614), and the Aluma Skin Renewal System (K051214), in that they are intended for use… | 1997 |
| * | K974346 | Starlight Pulsed Diode Array Laser SystemSummary page 3…of Intense Pulsed-Light (IPL) and IPIJNd:YAG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214). The small differences that exist in certain tec… | 1998 |
| * | K982940 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…sed-Light (IP) and IPLANd:YAG Laser Systems (K020839, K(024093, K(030342, K030527); * LightSheer Pulsed Diode Array Laser System (K(973324, K(974346, 1K982940, K(001746, K(003614); * Aluma Skin Renewal System (KO051214); IW. Product Description Lumenis One s… | 1999 |
| * | K001746 | Lightsheer Pulsed Diode Array Laser System (Family of Products)Summary page 3…IPL) and IP.L/Nd:YAG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, IC074346, IC982940, K001746, K003614), and the Aluma Skin Renewal System (K051214), in that they are intended for use for the same surgic… | 2000 |
| * | K003614 | Lightsheer Pulsed Diode Array Laser SystemSummary page 3…IP.L/Nd:YAG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, IC074346, IC982940, K001746, K003614), and the Aluma Skin Renewal System (K051214), in that they are intended for use for the same surgical, aesth… | 2001 |
| * | K051214 | Aluma Skin Renewal SystemSummary page 3…K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, IC074346, IC982940, K001746, K003614), and the Aluma Skin Renewal System (K051214), in that they are intended for use for the same surgical, aesthetic and cosmetic applications in general and plastic s… | 2005 |
What descends from it? (297)
See all 2975 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 11 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 6 of the 120 ancestors have a recall of any class.
- Of its descendants, K072564 (Alma Lasers, Ltd., 2008) has gone furthest, with 266 descendants of its own.
- 20 other devices also cite its predicate K020839.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows: Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm): The 515-1200 nm intense pulsed light wavelengths are indicated for: * The treatment of benign pigmented…
Read the full statement (378 words)
The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:
* The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
* The treatment of tattoos;
* The treatment of cutaneous lesions, including warts, scars and striae;
* The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte; leg veins and venous malformations;
* The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd:YAG laser is indicated for:
* The coagulation and hemostasis of vascular lesions and soft tissue, including:
- Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg;
* The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles;
* The non-ablative treatment of facial wrinkles.
LightSheer Diode Laser Wavelength (800 nm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:
* The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles;
* The treatment of vascular lesions, including angiomas, hemangiomas telangiectasia and other benign vascular lesions;
The treatment of leg veins;
The treatment of benign pigmented lesion;
The treatment of pseudofolliculitis barbae;
The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:
The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and rhytids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060448 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060448: Lumenis One Family of Systems; Lumenis One..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060448
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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