510(k) · Cleared
ClearedQuantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 11, 2002 as substantially equivalent to K991935 (Esc Medical Systems, Ltd., 2000) and 10 other predicates after a 210-day review. Its family tree reaches back 5 generations to 1992. 1,046 later devices descend from it.
- Decided
- Oct 11, 2002
- Review
- 210 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 5 generations to K910422 (1992). 49 ancestors in all, the oldest K892514 (1990). 1,046 later devices descend from it, 21 citing it directly.
- Root · 5 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 4 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 3 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 2 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 1 generation backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- This deviceK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- Descendant · cites it directly · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
- Descendant · cites it directly · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled
- Descendant · cites it directly · 756 of its ownK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- Descendant · 2 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 569 of its ownK032460 Profile BBL SystemSciton, Inc · 2003
Showing 5 of 1,046 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,046 · See all- K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · cites it directly856descendants
- K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · cites it directly756descendants
- K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd. · 2003 · cites it directly756descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · 2 generations on737descendants
- K032460Profile BBL SystemSciton, Inc · 2003 · cites it directly569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −4 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −3 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −2 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −1 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| 0 (this device) | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| +1 | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | Lumenis | 2003 | — |
| +1 | K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems | Lumenis, Ltd. | 2003 | 1 |
| +1 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
| +2 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +1 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 16 | 0 |
| 2006 | 21 | 0 |
| 2007 | 24 | 0 |
| 2008 | 39 | 0 |
| 2009 | 25 | 0 |
| 2010 | 27 | 0 |
| 2011 | 26 | 0 |
| 2012 | 22 | 0 |
| 2013 | 35 | 0 |
| 2014 | 37 | 0 |
| 2015 | 41 | 0 |
| 2016 | 49 | 0 |
| 2017 | 53 | 0 |
| 2018 | 45 | 0 |
| 2019 | 37 | 0 |
| 2020 | 53 | 0 |
| 2021 | 49 | 0 |
| 2022 | 76 | 0 |
| 2023 | 65 | 0 |
| 2024 | 91 | 0 |
| 2025 | 127 | 0 |
| 2026 | 73 | 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? (11)
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 |
|---|---|---|---|
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 1…r Systems Primary Classification Name: Laser Powered Surgical Instrument (and Accessories) 111. Predicate Devices 0 ESC Medical Systems EpiLight (K991935, K994014); ESC Medical Systems MultiLight (K994014); ESC Medical Systems Photoderm HR (K991935);… | 2000 |
| * | K994014 | Esc Intense Pulsed Light Systems: Epilight and MultilightSummary page 1…Primary Classification Name: Laser Powered Surgical Instrument (and Accessories) 111. Predicate Devices 0 ESC Medical Systems EpiLight (K991935, K994014); ESC Medical Systems MultiLight (K994014); ESC Medical Systems Photoderm HR (K991935); ESC Phot… | 2000 |
| * | K980537 | ND: Yag Accessory for Photoderm SystemSummary page 1…K991935, K994014); ESC Medical Systems MultiLight (K994014); ESC Medical Systems Photoderm HR (K991935); ESC Photoderm Nd:YAG Accessory (K980537); ESC Photoderm PL (K960772); ESC Photoderm VL (K950493); Candela SPTL-le Pulsed Dye laser syste… | 1998 |
| * | K960772 | Photoderm PL.Summary page 1…al Systems MultiLight (K994014); ESC Medical Systems Photoderm HR (K991935); ESC Photoderm Nd:YAG Accessory (K980537); ESC Photoderm PL (K960772); ESC Photoderm VL (K950493); Candela SPTL-le Pulsed Dye laser system (KO1 1092); Candela Dynami… | 1996 |
| * | K950493 | Photoderm VL.Summary page 1…ESC Medical Systems Photoderm HR (K991935); ESC Photoderm Nd:YAG Accessory (K980537); ESC Photoderm PL (K960772); ESC Photoderm VL (K950493); Candela SPTL-le Pulsed Dye laser system (KO1 1092); Candela Dynamic Cooling Devices (KOO1589, K95 1033);… | 1995 |
| * | K011092 | Candela SPTL-1E Pulsed Dye Laser | 2001 |
| * | K001589 | Candela Dynamic Cooling Device | 2000 |
| * | K951033 | Andela Dynamic Cooling DeviceSummary page 1…PL (K960772); ESC Photoderm VL (K950493); Candela SPTL-le Pulsed Dye laser system (KO1 1092); Candela Dynamic Cooling Devices (KOO1589, K95 1033); MedArt 520 Cooling System (K000503); OptoMed DermaCool Skin Cooling Device (K990417); and Cohe… | 1996 |
| * | K000503 | Medart 520 Cooling SystemSummary page 1…93); Candela SPTL-le Pulsed Dye laser system (KO1 1092); Candela Dynamic Cooling Devices (KOO1589, K95 1033); MedArt 520 Cooling System (K000503); OptoMed DermaCool Skin Cooling Device (K990417); and Coherent Epidermal Chiller Tip (K960032). IV.… | 2000 |
| * | K990417 | DermacoolSummary page 1…1092); Candela Dynamic Cooling Devices (KOO1589, K95 1033); MedArt 520 Cooling System (K000503); OptoMed DermaCool Skin Cooling Device (K990417); and Coherent Epidermal Chiller Tip (K960032). IV. Product Description Lumenis Family of Intense Pulsed… | 1999 |
| * | K960032 | Coherent Versapulse Aesthetic Surgical LasersSummary page 1…89, K95 1033); MedArt 520 Cooling System (K000503); OptoMed DermaCool Skin Cooling Device (K990417); and Coherent Epidermal Chiller Tip (K960032). IV. Product Description Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comp… | 1996 |
What descends from it? (1,046)
See all 1,04621 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | 2003 | 856 |
| K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems | 2003 | 756 |
| K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and… | 2003 | 756 |
| K032460 | Profile BBL System | 2003 | 569 |
| K030426 | Omnilux Red | 2003 | 563 |
| K041086 | Palomar Starlux Pulsed Light System | 2005 | 365 |
| K060448 | Lumenis One Family of Systems; Lumenis One. | 2006 | 297 |
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
| K043329 | Omnilux Revive and Blue | 2005 | 202 |
| K082033 | Nannolight Intense Pulsed Light System | 2008 | 159 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 49 ancestors has a recall of any class.
- Of its descendants, K030527 (Lumenis, 2003) has gone furthest, with 856 descendants of its own.
- 9 other devices also cite its predicate K991935.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows: Intense Pulsed Light…
Read the full statement (367 words)
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm):
The 515 - 1200 nm intense pulsed light wavelengths are indicated for:
The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae;
The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanerd, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd:YAG laser is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including:
Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Real Time Chiller:
The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment;
Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020839
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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