510(k) · Cleared
ClearedResurfx 1565NM Laser Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Sep 3, 2013 as substantially equivalent to K091420 (Solta Medical, Inc., 2009) and 1 other predicate after a 243-day review. Its family tree reaches back 17 generations to 1992. 41 later devices descend from it.
- Decided
- Sep 3, 2013
- Review
- 243 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K910422 (1992). 252 ancestors in all, the oldest K820106 (1982). 41 later devices descend from it, 4 citing it directly.
- Root · 17 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations between
- 3 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 2 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 1 generation backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- This deviceK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- Descendant · cites it directly · 38 of its ownK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 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 · cites it directly · 4 of its ownK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
Show all 17 generations
- Root · 17 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 16 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 15 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 14 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 13 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 12 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 11 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 10 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 9 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 8 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 7 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 6 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 5 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 4 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 3 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 2 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 1 generation backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- This deviceK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K142860Lumenis M22 SystemLumenis, Ltd. · 2015 · cites it directly38descendants
- 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 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −16 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −15 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −14 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −13 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −12 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −11 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −10 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −9 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −8 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −7 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −6 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −5 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −4 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −3 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −2 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −1 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| 0 (this device) | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| +1 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| +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 | — |
| +1 | K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1993 | 8 | 0 |
| 1994 | 13 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 15 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 18 | 0 |
| 2001 | 22 | 0 |
| 2002 | 27 | 0 |
| 2003 | 23 | 0 |
| 2004 | 13 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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 ONG? 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 ONG device
- #1 K250402 AVAVA™ Skin Treatment Systemscore 19.1 · 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? (3)
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 |
|---|---|---|---|
| * | K091420 | Fraxel RE: Store Laser System, Model SR1500Summary page 2…the following predicate devices is claimed: Device Name 510k No Date of Clearance Fraxel (Solta medical) K091420 Oct 14 2009 1550 nm laser _________________ Palomar… | 2009 |
| * | K110907 | Palomar Icon (TM) Aesthetic SystemSummary page 2…ar K915 Nv2,20 Lux1540 915 Nv2,20 Palomar Icon Aesthetic K110907 June 22, 2011 System ____________________ Performance Standards… | 2011 |
| * | — | Palomar Lux1540 Named without a submission number |
What descends from it? (41)
See all 414 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 21 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 9 of the 252 ancestors have a recall of any class.
- Of its descendants, K142860 (Lumenis, Ltd., 2015) has gone furthest, with 38 descendants of its own.
- 2 other devices also cite its predicate K091420.
How does its category compare?
All ONG devicesONG Powered Laser Surgical Instrument With MicrobeamFractional Output: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ONG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONG
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONG
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONG
1in 2025
MAUDE reports naming product code ONG, 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 | 0 | — | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 4 | 176 | 1 | 3 |
| 2011 | 6 | 122 | 0 | 2 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 3 | 243 | 0 | 4 |
| 2014 | 2 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 40 |
| 2018 | 2 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 3 | 203 | 0 | 2 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 1 | — | 2 | 11 |
| 2025 | 4 | 97 | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 1565nm ResurFX laser module is indicated for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130028: Resurfx 1565NM Laser Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130028
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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