510(k) · Cleared
ClearedEpilaser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epilady 2000, LLC · GEX Powered Laser Surgical Instrument
Cleared on Sep 1, 2017 as substantially equivalent to K090820 (Spectragenics, Inc., 2009) and 1 other predicate after a 154-day review. Its family tree reaches back 12 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 1, 2017
- Review
- 154 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K950019 (1995). 29 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 8 generations between
- 3 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 2 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 1 generation backK120737 Tria Laser Hair Removal SystemTria Beauty, Inc. · 2012
- This deviceK170970 EpilaserEpilady 2000, LLC · 2017
- Descendant · cites it directly · 1 of its ownK213105 Epilaser AbsoluteEpilady 2000, LLC · 2022
- Descendant · cites it directly · 0 of its ownK233224 Epilaser ProEpilady 2000, LLC · 2024
Show all 12 generations
- Root · 12 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 11 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 10 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 9 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 8 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 7 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 6 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 5 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 4 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 3 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 2 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 1 generation backK120737 Tria Laser Hair Removal SystemTria Beauty, Inc. · 2012
- This deviceK170970 EpilaserEpilady 2000, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −11 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −10 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −9 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −8 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −7 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −6 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −5 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −4 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −3 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −2 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −1 | K120737 | Tria Laser Hair Removal System | Tria Beauty, Inc. | 2012 | — |
| 0 (this device) | K170970 | Epilaser | Epilady 2000, LLC | 2017 | — |
| +1 | K213105 | Epilaser Absolute | Epilady 2000, LLC | 2022 | — |
| +1 | K233224 | Epilaser Pro | Epilady 2000, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K090820 | Tria Hair Removal Laser SystemSummary page 4…aser surgical instrument for use in general and plastic surgery and in dermatology, class II Predicate Devices TRIA Laser Hair Removal System, TRIA Beauty, Inc. (K090820, K120737) Device Description The Epilaser is an over-the-counter, hand-held, hair removal device intended for hair removal o… | 2009 |
| * | K120737 | Tria Laser Hair Removal SystemSummary page 4…ical instrument for use in general and plastic surgery and in dermatology, class II Predicate Devices TRIA Laser Hair Removal System, TRIA Beauty, Inc. (K090820, K120737) Device Description The Epilaser is an over-the-counter, hand-held, hair removal device intended for hair removal on the… | 2012 |
What descends from it? (2)
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 22 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K213105 (Epilady 2000, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K090820.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170970 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170970: Epilaser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170970
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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