510(k) · Cleared
ClearedPalomar Vectus Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 23, 2012 as substantially equivalent to K053628 (Lumenis, Inc., 2006) and 3 other predicates after an 83-day review. Its family tree reaches back 17 generations to 1992. 4 later devices descend from it.
- Decided
- May 23, 2012
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K910422 (1992). 255 ancestors in all, the oldest K820106 (1982). 4 later devices descend from it, 2 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 deviceK120622 Palomar Vectus LaserPalomar Medical Technologies, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK193426 Elite iQCynosure, LLC · 2020
- Descendant · cites it directly · 1 of its ownK162765 Venus Velocity Diode Laser SystemVenus Concept, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK240396 Elite iQ PRO (M122K1)Cynosure, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK200786 Venus EpileveVenus Concept USA, Inc. · 2020
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 deviceK120622 Palomar Vectus LaserPalomar Medical Technologies, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K193426Elite iQCynosure, LLC · 2020 · cites it directly1descendant
- K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd. · 2017 · cites it directly1descendant
- K240396Elite iQ PRO (M122K1)Cynosure, LLC · 2024 · 2 generations on0descendants
- K200786Venus EpileveVenus Concept USA, Inc. · 2020 · 2 generations on0descendants
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) | K120622 | Palomar Vectus Laser | Palomar Medical Technologies, Inc. | 2012 | — |
| +1 | K193426 | Elite iQ | Cynosure, LLC | 2020 | — |
| +1 | K162765 | Venus Velocity Diode Laser System | Venus Concept, Ltd. | 2017 | — |
| +2 | K240396 | Elite iQ PRO (M122K1) | Cynosure, LLC | 2024 | — |
| +2 | K200786 | Venus Epileve | Venus Concept USA, Inc. | 2020 | — |
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 | 23 | 0 |
| 2002 | 27 | 0 |
| 2003 | 23 | 0 |
| 2004 | 13 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2024 | 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 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? (4)
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 |
|---|---|---|---|
| * | K053628 | Lightsheer Duet Laser SystemSummary page 1…(21 CFR § 878.4810) PRODUCT CODE: GEX 3. PREDICATE DEVICES Lumenis, Inc. LightSheer Duet Laser System K053628 Milesman, S.L. Milesman Premium Pulsed Diode Array Laser K073300 Sandstone Medical Technologies, In… | 2006 |
| * | K073300 | Milesman PremiumSummary page 1…PREDICATE DEVICES Lumenis, Inc. LightSheer Duet Laser System K053628 Milesman, S.L. Milesman Premium Pulsed Diode Array Laser K073300 Sandstone Medical Technologies, Inc. The Cheveux Diode Laser System K100893 Palomar Medical Technol… | 2007 |
| * | K100893 | Cheveux Diode Laser SystemSummary page 1…Milesman, S.L. Milesman Premium Pulsed Diode Array Laser K073300 Sandstone Medical Technologies, Inc. The Cheveux Diode Laser System K100893 Palomar Medical Technologies, Inc. SkintelTM Reader Ki110907 PALOMAR MEDICAL TECHNOLOGIES, INC.… | 2010 |
| * | K110907 | Palomar Icon (TM) Aesthetic SystemSummary page 1…Sandstone Medical Technologies, Inc. The Cheveux Diode Laser System K100893 Palomar Medical Technologies, Inc. SkintelTM Reader Ki110907 PALOMAR MEDICAL TECHNOLOGIES, INC. PAGE 1 OF 2 PALOMAR VECTUs LASER 4.… | 2011 |
What descends from it? (4)
2 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 20 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 9 of the 255 ancestors have a recall of any class.
- Of its descendants, K193426 (Cynosure, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K053628.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Palomar Vectus Laser is intended for all Fitzpatrick skin types, including tanned skin for use In aesthetic, dermatology, general and plastic surgery applications for the treatment of:
The treatment of vascular lesions, such as angiomas, hemangiomas, telangiectasia and other benign vascular lesions.
Treatment of leg veins.
The treatment of benign pigmented lesions.
Hair removal and permanent hair reduction.
Treatment of pseudofolliculitis barbae.
The SkinteT-M Reader is intended as an objective measurement tool for examining skin. melanin content for determining and setting a test spot starting fluence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120622: Palomar Vectus Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120622
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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