510(k) · Cleared
ClearedM22 and ResurFx Systems
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 Aug 9, 2017 as substantially equivalent to K142860 (Lumenis, Ltd., 2015) and 1 other predicate after a 215-day review. Its family tree reaches back 19 generations to 1992. 24 later devices descend from it.
- Decided
- Aug 9, 2017
- Review
- 215 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K910422 (1992). 322 ancestors in all, the oldest K800617 (1980). 24 later devices descend from it, 5 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 deviceK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- Descendant · cites it directly · 12 of its ownK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- Descendant · cites it directly · 5 of its ownK203441 The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK222790 F65 Laser SystemLumenis Be, Ltd. · 2023
- Descendant · 3 generations on · 3 of its ownK221268 SR-1 Skin Treatment SystemAVAVA, Inc. · 2022
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 deviceK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020 · cites it directly12descendants
- K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021 · cites it directly5descendants
- K202884SR-1 Skin Treatment SystemAVAVA, Inc. · 2021 · 2 generations on4descendants
- K222790F65 Laser SystemLumenis Be, Ltd. · 2023 · 2 generations on3descendants
- K221268SR-1 Skin Treatment SystemAVAVA, Inc. · 2022 · 3 generations on3descendants
View 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) | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| +1 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020 | — |
| +1 | K203441 | The Alma Hybrid Laser System | Alma Lasers, Ltd. | 2021 | — |
| +2 | K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021 | — |
| +2 | K222790 | F65 Laser System | Lumenis Be, Ltd. | 2023 | — |
| +3 | K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | 2022 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 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? (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 |
|---|---|---|---|
| * | K142860 | Lumenis M22 SystemSummary page 5…Class II Regulation Number: 21 CFR 878.4810 Panel: General & Plastic Surgery Predicate Device: M22 System, cleared under K142860 ResurFX module, cleared under K130028 Indications for Use: The complete phrasing of the ind… | 2015 |
| * | K130028 | Resurfx 1565NM Laser ModuleSummary page 5…General & Plastic Surgery Predicate Device: M22 System, cleared under K142860 ResurFX module, cleared under K130028 Indications for Use: The complete phrasing of the indications for use statement for the Lum… | 2013 |
| † | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | 2002 |
What descends from it? (24)
See all 245 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 25 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 322 ancestors have a recall of any class.
- Of its descendants, K193500 (Lumenis, Ltd., 2020) has gone furthest, with 12 descendants of its own.
- 5 other devices also cite its predicate K142860.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 different filters) is indicated for: Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides…
Read the full statement (318 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:
The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 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)
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
ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
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 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.
The ResurFX System with wavelength of 1565 nm, is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170060: M22 and ResurFx Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170060
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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