510(k) · Cleared
Recalled · Class II · 2024Medical Non-Ablative Fractional Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wingderm Electro-Optics, Ltd. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Apr 30, 2020 as substantially equivalent to K170060 (Lumenis, Ltd., 2017) after a 245-day review. Its family tree reaches back 20 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 30, 2020
- Review
- 245 days
- Class
- Class II
- Product code
- ONG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 20 generations to K910422 (1992). 323 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 20 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 16 generations between
- 3 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 2 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 1 generation backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- This deviceK192350 Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK221770 Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK251031 Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd. · 2025
Show all 20 generations
- Root · 20 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 19 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 18 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 17 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 16 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 15 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 14 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 13 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 12 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 11 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 10 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 9 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 8 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 7 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 6 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 5 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 4 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 3 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 2 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 1 generation backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- This deviceK192350 Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −19 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −18 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −17 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −16 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −15 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −14 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −13 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −12 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −11 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −10 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −9 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −8 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −7 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −6 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −5 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −4 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −3 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −2 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| −1 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| 0 (this device) | K192350 | Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics, Ltd. | 2020 | — |
| +1 | K221770 | Fiber Laser Treatment System | Shanghai Apolo Medical Technology Co., Ltd. | 2022 | — |
| +2 | K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K170060 | M22 and ResurFx SystemsSummary page 6…3‐2 510(k) Summary 6. Identification of Predicate Device Predicate Device: 510(k) Number: K170060 Product Name: M22 And Resurfx Systems Manufacturer: Lumenis, Ltd. 7. Non-Clinical Test Conclusion Non clinic… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221770 | Fiber Laser Treatment System | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2024 | Class II | Z-0555-2025 | Radiation Control for Health and Safety Act | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 323 ancestors have a recall of any class.
- Of its descendants, K221770 (Shanghai Apolo Medical Technology Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K170060.
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. 2020, 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 Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended 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/K192350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192350: Medical Non-Ablative Fractional Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192350
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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