510(k) · Cleared
ClearedPhotoderm 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 May 20, 1998 as substantially equivalent to K963249 (Esc Medical Systems, Ltd., 1997) and 4 other predicates after a 169-day review. Its family tree reaches back 3 generations to 1992. 1,496 later devices descend from it.
- Decided
- May 20, 1998
- Review
- 169 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K910422 (1992). 10 ancestors in all, the oldest K892514 (1990). 1,496 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 2 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 1 generation backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- This deviceK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- Descendant · cites it directly · 1,492 of its ownK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- Descendant · cites it directly · 1,129 of its ownK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- Descendant · 2 generations on · 1,127 of its ownK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- Descendant · cites it directly · 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
Showing 5 of 1,496 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,496 · See all- K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000 · cites it directly1,492descendants
- K013366Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002 · cites it directly1,129descendants
- K022568Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairMedical Bio Care Sweden AB · 2002 · 2 generations on1,127descendants
- 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 · 2 generations on1,046descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −2 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −1 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| 0 (this device) | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| +1 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| +1 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| +2 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| +1 | 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 | — |
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 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 11 | 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…00 Fax: 001-972-4-959-9050 Name of device: PhotoDerm® HR - Predicate devices: 1. EpiLight™ Hair Removal System made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K963249. 2. LT-100 ND:YAG Laser Hair Removal System made by Thermolase Corporation of San Diego, California. 510(k) #K950019. 3. SLS Ch… | 1997 |
| * | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Summary page 1…by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K963249. 2. LT-100 ND:YAG Laser Hair Removal System made by Thermolase Corporation of San Diego, California. 510(k) #K950019. 3. SLS Chromos 694 QD Ruby Laser made by Classy Lady by MEHL of Gainesville, Florida. 510(k) #K962109. . 4. Epilaser Normal Mo… | 1995 |
| * | K962109 | SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair RemovalSummary page 1…made by Thermolase Corporation of San Diego, California. 510(k) #K950019. 3. SLS Chromos 694 QD Ruby Laser made by Classy Lady by MEHL of Gainesville, Florida. 510(k) #K962109. . 4. Epilaser Normal Mode Ruby Laser made by Spectrum Medical Technologies of Lexington, Massachusetts. 510(k) #K963947. 5. Sh… | 1997 |
| * | K963947 | Epilaser Normal Mode Ruby LaserSummary page 1…y Lady by MEHL of Gainesville, Florida. 510(k) #K962109. . 4. Epilaser Normal Mode Ruby Laser made by Spectrum Medical Technologies of Lexington, Massachusetts. 510(k) #K963947. 5. Sharplan Ruby Laser System made by Sharplan Lasers, Inc of Allendale, New Jersey. 510(k) #K962446. Description vice: PhotoD… | 1997 |
| * | K962446 | Sharplan Ruby Laser SystemSummary page 1…Spectrum Medical Technologies of Lexington, Massachusetts. 510(k) #K963947. 5. Sharplan Ruby Laser System made by Sharplan Lasers, Inc of Allendale, New Jersey. 510(k) #K962446. Description vice: PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted ha… | 1997 |
What descends from it? (1,496)
See all 1,4963 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 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K991935 (Esc Medical Systems, Ltd., 2000) has gone furthest, with 1,492 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?
The PhotoDerm® HR is used for the removal of unwanted hair.
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/K974536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974536: 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/K974536
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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