510(k) · Cleared
ClearedEpilaser Absolute
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 Dec 13, 2022 as substantially equivalent to K170970 (Epilady 2000, LLC, 2017) and 1 other predicate after a 445-day review. Its family tree reaches back 17 generations to 1995. 1 later device descends from it.
- Decided
- Dec 13, 2022
- Review
- 445 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K943450 (1995). 244 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 2 generations backK090762 LEDAQuantel Derma GmbH · 2009
- 1 generation backK141063 Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH · 2014
- This deviceK213105 Epilaser AbsoluteEpilady 2000, LLC · 2022
- Descendant · cites it directly · 0 of its ownK233224 Epilaser ProEpilady 2000, LLC · 2024
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 3 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 2 generations backK090762 LEDAQuantel Derma GmbH · 2009
- 1 generation backK141063 Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH · 2014
- This deviceK213105 Epilaser AbsoluteEpilady 2000, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K233224Epilaser ProEpilady 2000, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −4 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −3 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −2 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| −1 | K141063 | Linscan 808, Linscan 980 | Gme (German Medical Engineering) GmbH | 2014 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 10 | 0 |
| 1995 | 13 | 0 |
| 1996 | 17 | 0 |
| 1997 | 21 | 0 |
| 1998 | 12 | 0 |
| 1999 | 9 | 0 |
| 2000 | 21 | 0 |
| 2001 | 24 | 0 |
| 2002 | 29 | 0 |
| 2003 | 20 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K170970 | Epilaser Our reading of the summary gave K170790, FDA’s number for SAM CRRT Unit, SAM Cassette CRRT (Spectral Medical, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Epilaser”. | 2017 |
| * | K141063 | Linscan 808, Linscan 980Summary page 4…Name: 21 CFR 878.4810, Class II, GEX , Laser surgical instrument for use in general and plastic surgery and in dermatology Predicate Devices K170790 Epilaser K141063 LinScan System Device Description The Epilaser Absolute is an over-the-counter, hand-held, hair removal device. It kil… | 2014 |
| † | K120737 | Tria Laser Hair Removal System | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233224 | Epilaser Pro | 2024 | 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 27 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 10 of the 244 ancestors have a recall of any class.
- Of its descendants, K233224 (Epilady 2000, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K170970.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Absolute 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/K213105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213105: Epilaser Absolute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213105
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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