510(k) · Cleared
ClearedEpilight Hair Removal System, Photoderm HR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esc Medical Systems, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 27, 2000 as substantially equivalent to K963249 (Esc Medical Systems, Ltd., 1997) and 4 other predicates after a 232-day review. Its family tree reaches back 4 generations to 1992. 1,492 later devices descend from it.
- Decided
- Jan 27, 2000
- Review
- 232 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K910422 (1992). 16 ancestors in all, the oldest K892514 (1990). 1,492 later devices descend from it, 10 citing it directly.
- Root · 4 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 3 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 2 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 1 generation backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- This deviceK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- Descendant · cites it directly · 1,117 of its ownK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- Descendant · cites it directly · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- Descendant · cites it directly · 1,018 of its ownK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- Descendant · 2 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
- Descendant · 2 generations on · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled
Showing 5 of 1,492 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,492 · See all- K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003 · cites it directly1,117descendants
- K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · cites it directly1,046descendants
- K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002 · cites it directly1,018descendants
- K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 2 generations on856descendants
- K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · 2 generations on756descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −3 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −2 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −1 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| 0 (this device) | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| +1 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| +1 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| +1 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| +2 | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | Lumenis | 2003 | — |
| +2 | K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems | Lumenis, Ltd. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 8 | 0 |
| 2003 | 23 | 0 |
| 2004 | 14 | 0 |
| 2005 | 26 | 0 |
| 2006 | 27 | 0 |
| 2007 | 32 | 0 |
| 2008 | 49 | 0 |
| 2009 | 37 | 0 |
| 2010 | 38 | 0 |
| 2011 | 37 | 0 |
| 2012 | 35 | 0 |
| 2013 | 55 | 0 |
| 2014 | 61 | 0 |
| 2015 | 52 | 0 |
| 2016 | 70 | 0 |
| 2017 | 69 | 0 |
| 2018 | 63 | 0 |
| 2019 | 55 | 0 |
| 2020 | 62 | 0 |
| 2021 | 79 | 0 |
| 2022 | 114 | 0 |
| 2023 | 107 | 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? (5)
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 |
|---|---|---|---|
| * | K963249 | Epilight Hair Removal SystemSummary page 1…972-4-959-9050 Names of devices: EpiLight®, PhotoDerm® HR Predicate devices: 1) EpiLight® Hair Removal System, made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K963249 2) PhotoDerm® HR , Made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K974536 3) EpiLaser™ Normal Mode Ruby Laser made by… | 1997 |
| * | K974536 | Photoderm HR SystemSummary page 1…piLight® Hair Removal System, made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K963249 2) PhotoDerm® HR , Made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K974536 3) EpiLaser™ Normal Mode Ruby Laser made by Palomar Medical Products of N. Carolina USA. 510(k) #980517. 4) LightSheer™ Long Pu… | 1998 |
| * | K980517 | Epilaser Normal Mode Ruby LaserSummary page 1…m® HR , Made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K974536 3) EpiLaser™ Normal Mode Ruby Laser made by Palomar Medical Products of N. Carolina USA. 510(k) #980517. 4) LightSheer™ Long Pulse Ruby Laser made by Palomar Medical Products of N. Carolina USA. 510(k) #982980. 5) LightSheer™ Pulse… | 1998 |
| * | K982980 | Lightsheer Long Pulse Ruby LaserSummary page 1…r made by Palomar Medical Products of N. Carolina USA. 510(k) #980517. 4) LightSheer™ Long Pulse Ruby Laser made by Palomar Medical Products of N. Carolina USA. 510(k) #982980. 5) LightSheer™ Pulsed Diode Array Laser System made by Star Medical Technologies of Pleasanton CA, USA 510(k) #K982940. Descri… | 1999 |
| * | K982940 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…omar Medical Products of N. Carolina USA. 510(k) #982980. 5) LightSheer™ Pulsed Diode Array Laser System made by Star Medical Technologies of Pleasanton CA, USA 510(k) #K982940. Description of device: EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal tre… | 1999 |
What descends from it? (1,492)
See all 1,49210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023954 | Altus Medical Coolglide Laser Systems and Accessories | 2003 | 1,117 |
| K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | 2002 | 1,046 |
| K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | 2002 | 1,018 |
| K021149 | Aurora DS | 2002 | 750 |
| K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 | 739 |
| K103184 | Silk'n Flash N GO | 2010 | 148 |
| K043255 | Ellipse Light SPT | 2005 | 25 |
| K023081 | Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction) | 2002 | 23 |
| K052371 | Depilite EL-8B Series Dermo Flash Systems | 2006 | 0 |
| K031680 | Spectrapulse | 2003 | 0 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K023954 (Altus Medical, Inc., 2003) has gone furthest, with 1,117 descendants of its own.
- 6 other devices also cite its predicate K963249.
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?
EpiLight® is used for the removal of unwanted hair.
EpiLight®is also intended to effect stable long-term, or permanent hair reduction in skin types I-V 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.
PhotoDerm® HR is used for the removal of unwanted hair.
PhotoDerm® HR is also intended to effect stable long-term, or permanent hair reduction in skin types I-V 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/K991935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991935: Epilight Hair Removal System, Photoderm HR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991935
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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