510(k) · Cleared
Recalled · Class II · 2015Lumenis M22 System
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 Jan 21, 2015 as substantially equivalent to K060448 (Lumenis, Ltd., 2006) and 5 other predicates after a 112-day review. Its family tree reaches back 18 generations to 1992. 38 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 18 generations to K910422 (1992). 321 ancestors in all, the oldest K800617 (1980). 38 later devices descend from it, 6 citing it directly.
- Root · 18 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 14 generations between
- 3 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 2 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 1 generation backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- This deviceK142860 Lumenis M22 SystemLumenis, Ltd. · 2015
- Descendant · cites it directly · 24 of its ownK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- Descendant · 2 generations on · 12 of its ownK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- Descendant · 2 generations on · 5 of its ownK203441 The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021
- Descendant · 3 generations on · 4 of its ownK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
Show all 18 generations
- Root · 18 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 17 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 16 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 15 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 14 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 13 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 12 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 11 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 10 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 9 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 8 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 7 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 6 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 5 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 4 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 3 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 2 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 1 generation backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- This deviceK142860 Lumenis M22 SystemLumenis, Ltd. · 2015
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K170060M22 and ResurFx SystemsLumenis, Ltd. · 2017 · cites it directly24descendants
- K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020 · 2 generations on12descendants
- K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021 · 2 generations on5descendants
- K202884SR-1 Skin Treatment SystemAVAVA, Inc. · 2021 · 3 generations on4descendants
- K192539Deka LuxeaEl.En Electronic Engineering Spa · 2019 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −17 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −16 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −15 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −14 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −13 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −12 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −11 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −10 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −9 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −8 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −7 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −6 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −5 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −4 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −3 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −2 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −1 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| 0 (this device) | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | — |
| +1 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| +2 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020 | — |
| +2 | K203441 | The Alma Hybrid Laser System | Alma Lasers, Ltd. | 2021 | — |
| +3 | K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021 | — |
| +1 | K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019 | — |
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 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 24 | 0 |
| 1998 | 19 | 0 |
| 1999 | 13 | 0 |
| 2000 | 26 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 30 | 0 |
| 2004 | 17 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 8…to the following predicate devices is claimed: Device Name 510k No Date of Clearance Lumenis Lum One K060448 July 5, 2006 Lumenis LUME 2 K083733 May 04, 2009 Lumenis ResurFX laser… | 2006 |
| * | K083733 | Lume 2 System, Model GA0005000Summary page 7…enis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces: • Universal Intense Pulsed Light (IPL) handpiece (K083733) • Multi-Spot Nd:YAG laser handpiece (K083733) • ResurFX non-ablative laser handpiece (K130028) • Q-Switched Nd… | 2009 |
| * | K130028 | Resurfx 1565NM Laser ModuleSummary page 7…eces: • Universal Intense Pulsed Light (IPL) handpiece (K083733) • Multi-Spot Nd:YAG laser handpiece (K083733) • ResurFX non-ablative laser handpiece (K130028) • Q-Switched Nd:YAG laser handpiece (K043173) Intended Use Statement: The subject Lumenis M22 System has connection c… | 2013 |
| * | K043173 | Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesSummary page 7…handpiece (K083733) • Multi-Spot Nd:YAG laser handpiece (K083733) • ResurFX non-ablative laser handpiece (K130028) • Q-Switched Nd:YAG laser handpiece (K043173) Intended Use Statement: The subject Lumenis M22 System has connection capability with the following available treatment ha… | 2005 |
| * | K040081 | Palomar Luxv HandpieceSummary page 8…Lumenis Quantum Q K043173 Jan 1, 2005 switched Nd:YAG Palomar LuxV K040081 April 1, 2004 Candela Nd:YAG laser K063074 Dec 27, 2006… | 2004 |
| * | K063074 | Candela 3630 Laser SystemSummary page 8…switched Nd:YAG Palomar LuxV K040081 April 1, 2004 Candela Nd:YAG laser K063074 Dec 27, 2006 System 2-4… | 2006 |
What descends from it? (38)
See all 386 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2015 | Class II | Z-1669-2016 | Device Design | Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 15 of the 321 ancestors have a recall of any class.
- Of its descendants, K170060 (Lumenis, Ltd., 2017) has gone furthest, with 24 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. 2015, 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 subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: 1. The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 different filters) is indicated for: • Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides…
Read the full statement (309 words)
The subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
1. The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 different filters) is indicated for:
• 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, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
• 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
• Mild to moderate inflammatory Acne (Acne vulgaris)
2. The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) 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, 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
3. ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
• Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue
4. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for:
• Removal of dark tattoos
• Treatment of pigmented lesions
*Note
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142860: Lumenis M22 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142860
Report an extraction error
Are you the manufacturer?
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