510(k) · Cleared
ClearedLume 2 System, Model GA0005000
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 May 4, 2009 as substantially equivalent to K060448 (Lumenis, Ltd., 2006) after a 139-day review. Its family tree reaches back 14 generations to 1995. 39 later devices descend from it.
- Decided
- May 4, 2009
- Review
- 139 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K943450 (1995). 121 ancestors in all, the oldest K800617 (1980). 39 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- This deviceK083733 Lume 2 System, Model GA0005000Lumenis, Ltd. · 2009
- Descendant · cites it directly · 38 of its ownK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 24 of its ownK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- Descendant · 3 generations on · 12 of its ownK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- Descendant · 3 generations on · 5 of its ownK203441 The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021
- Descendant · 4 generations on · 4 of its ownK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- This deviceK083733 Lume 2 System, Model GA0005000Lumenis, Ltd. · 2009
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K142860Lumenis M22 SystemLumenis, Ltd. · 2015 · cites it directly38descendants
- K170060M22 and ResurFx SystemsLumenis, Ltd. · 2017 · 2 generations on24descendants
- K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020 · 3 generations on12descendants
- K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021 · 3 generations on5descendants
- K202884SR-1 Skin Treatment SystemAVAVA, Inc. · 2021 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −1 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| 0 (this device) | K083733 | Lume 2 System, Model GA0005000 | Lumenis, Ltd. | 2009 | — |
| +1 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| +2 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| +3 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020 | — |
| +3 | K203441 | The Alma Hybrid Laser System | Alma Lasers, Ltd. | 2021 | — |
| +4 | K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K060448 | Lumenis One Family of Systems; Lumenis One.Summary page 1…and plastic surgery and in dermatology C. PREDICATE DEVICE: Lumenis One Family of Systems (K060448) D. DEVICE DESCRIPTION: The Lume 2 system is a multi-functional platform, computer controlled system which… | 2006 |
What descends from it? (39)
See all 391 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142860 | Lumenis M22 System | 2015 | 38 |
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 14 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 6 of the 121 ancestors have a recall of any class.
- Of its descendants, K142860 (Lumenis, Ltd., 2015) has gone furthest, with 38 descendants of its own.
- 4 other devices also cite its predicate K060448.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of: Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos. Cutaneous lesions, including warts, scars and striae. Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg…
Read the full statement (195 words)
The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of:
Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos.
Cutaneous lesions, including warts, scars and striae.
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and
For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
with Nd:YAG laser at wavelength 1064 nm, is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including the 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, an 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.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083733: Lume 2 System, Model GA0005000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083733
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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