510(k) · Cleared
ClearedLightsheer Pulsed Diode Array Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Star Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 8, 1999 as substantially equivalent to K973324 (Star Medical Technologies, Inc., 1997) after a 230-day review. Its family tree reaches back 3 generations to 1995. 1,526 later devices descend from it.
- Decided
- Apr 8, 1999
- Review
- 230 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950019 (1995). 4 ancestors in all. 1,526 later devices descend from it, 11 citing it directly.
- Root · 3 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 2 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 1 generation backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- This deviceK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- Descendant · cites it directly · 1,492 of its ownK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- Descendant · 2 generations on · 1,117 of its ownK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- Descendant · 2 generations on · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- Descendant · 2 generations on · 1,018 of its ownK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- Descendant · 3 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
Showing 5 of 1,526 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,526 · See all- K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000 · cites it directly1,492descendants
- K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003 · 2 generations on1,117descendants
- K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · 2 generations on1,046descendants
- K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002 · 2 generations on1,018descendants
- K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 3 generations on856descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −2 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −1 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| 0 (this device) | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| +1 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| +2 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| +2 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| +2 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| +3 | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | Lumenis | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 9 | 0 |
| 2003 | 28 | 0 |
| 2004 | 17 | 0 |
| 2005 | 29 | 0 |
| 2006 | 28 | 0 |
| 2007 | 32 | 0 |
| 2008 | 52 | 0 |
| 2009 | 39 | 0 |
| 2010 | 38 | 0 |
| 2011 | 39 | 0 |
| 2012 | 37 | 0 |
| 2013 | 56 | 0 |
| 2014 | 61 | 0 |
| 2015 | 54 | 0 |
| 2016 | 70 | 0 |
| 2017 | 71 | 0 |
| 2018 | 64 | 0 |
| 2019 | 55 | 0 |
| 2020 | 62 | 0 |
| 2021 | 79 | 0 |
| 2022 | 114 | 0 |
| 2023 | 109 | 0 |
| 2024 | 123 | 0 |
| 2025 | 162 | 0 |
| 2026 | 94 | 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? (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 |
|---|---|---|---|
| * | K973324 | Starlight Pulsed Diode Array Laser SystemSummary page 1…neral and Plastic Surgery and in Dermatology (see: 21 CFR 878-4810). Product Code: GEX Panel: 79 LightSheer™ Pulsed Diode Array Laser Star Medical Technologies, Inc. k973324 The LightSheer™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 — 30 ms, and… | 1997 |
What descends from it? (1,526)
See all 1,52611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991935 | Epilight Hair Removal System, Photoderm HR System | 2000 | 1,492 |
| K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 | 739 |
| K060448 | Lumenis One Family of Systems; Lumenis One. | 2006 | 297 |
| K994260 | Candela Gentlelase GL Dermatological Laser | 2000 | 258 |
| K011747 | Palomar LC 100 Diode Laser | 2001 | 174 |
| K032846 | Spectra Pulsed Diode Laser, Model DR-1 | 2003 | 173 |
| K052848 | Spectra Hair Removal Laser | 2005 | 172 |
| K053527 | Spectra Hair Removal Laser | 2008 | 169 |
| K090820 | Tria Hair Removal Laser System | 2009 | 167 |
| K090762 | LEDA | 2009 | 46 |
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 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K991935 (Esc Medical Systems, Ltd., 2000) has gone furthest, with 1,492 descendants of its own.
- 10 other devices also cite its predicate K973324.
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 LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982940: Lightsheer Pulsed Diode Array Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982940
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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