510(k) · Cleared
ClearedSpectra Hair Removal Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectragenics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 1, 2008 as substantially equivalent to K032846 (Spectragenics, Inc., 2003) and 13 other predicates after a 774-day review. Its family tree reaches back 8 generations to 1995. 169 later devices descend from it.
- Decided
- Feb 1, 2008
- Review
- 774 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 8 generations to K950019 (1995). 24 ancestors in all. 169 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 7 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 6 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 5 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 4 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 3 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 2 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 1 generation backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- This deviceK053527 Spectra Hair Removal LaserSpectragenics, Inc. · 2008
- Descendant · cites it directly · 168 of its ownK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- Descendant · cites it directly · 167 of its ownK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- Descendant · 2 generations on · 148 of its ownK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- Descendant · 2 generations on · 140 of its ownK103560 Shaser Ipl Hair Removal SystemShaser, Inc. · 2011
- Descendant · 3 generations on · 135 of its ownK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
Showing 5 of 169 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 169 · See all- K082298Flash N' GOHome Skinovations, Ltd. · 2008 · cites it directly168descendants
- K090820Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009 · cites it directly167descendants
- K103184Silk'n Flash N GOHome Skinovations, Ltd. · 2010 · 2 generations on148descendants
- K103560Shaser Ipl Hair Removal SystemShaser, Inc. · 2011 · 2 generations on140descendants
- K120080Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012 · 3 generations on135descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −7 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −6 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −5 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −4 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −3 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −2 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −1 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K053527 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2008 | — |
| +1 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| +1 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| +2 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| +2 | K103560 | Shaser Ipl Hair Removal System | Shaser, Inc. | 2011 | — |
| +3 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 22 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 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? (14)
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 |
|---|---|---|---|
| * | K032846 | Spectra Pulsed Diode Laser, Model DR-1Summary page 1…y Marketed Predicate Devices: Spectra Hair Removal Laser SpectraGenies, Inc. K032846, K052848 LightSheer (StarLight) pulsed diode laser… | 2003 |
| * | K052848 | Spectra Hair Removal Laser Cleared while this submission was under review Summary page 1…d Predicate Devices: Spectra Hair Removal Laser SpectraGenies, Inc. K032846, K052848 LightSheer (StarLight) pulsed diode laser… | 2005 |
| * | K973324 | Starlight Pulsed Diode Array Laser SystemSummary page 1…LightSheer (StarLight) pulsed diode laser Star Medical / Coherent Star K973324, K982940, K001746 SLP 1000 (LC 100) pulsed diode laser… | 1997 |
| * | K982940 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…LightSheer (StarLight) pulsed diode laser Star Medical / Coherent Star K973324, K982940, K001746 SLP 1000 (LC 100) pulsed diode laser… | 1999 |
| * | K001746 | Lightsheer Pulsed Diode Array Laser System (Family of Products)Summary page 1…Sheer (StarLight) pulsed diode laser Star Medical / Coherent Star K973324, K982940, K001746 SLP 1000 (LC 100) pulsed diode laser Palom… | 2000 |
| * | K013028 | Palomar SLP 1000Summary page 1…SLP 1000 (LC 100) pulsed diode laser Palomar Medical Technologies, Inc. K013028, K010580, K011747 Apex 800 pulsed diode laser… | 2001 |
| * | K010580 | Palomar SLP 1000Summary page 1…SLP 1000 (LC 100) pulsed diode laser Palomar Medical Technologies, Inc. K013028, K010580, K011747 Apex 800 pulsed diode laser Iride… | 2001 |
| * | K011747 | Palomar LC 100 Diode LaserSummary page 1…00 (LC 100) pulsed diode laser Palomar Medical Technologies, Inc. K013028, K010580, K011747 Apex 800 pulsed diode laser Iridex Corpora… | 2001 |
| * | K020849 | Apex 800 Laser System, Model Apex 800Summary page 1…Apex 800 pulsed diode laser Iridex Corporation K020849 F-I pulsed diode laser Opusmed, Inc.… | 2002 |
| * | K030235 | F1 Diode Laser SystemSummary page 2…K020849 F-I pulsed diode laser Opusmed, Inc. K030235 SpaTouch® PhotoEpilation System Radiancy (Israel) Ltd.… | 2003 |
| * | K020856 | Spatouch Photoepilation SystemSummary page 2…K030235 SpaTouch® PhotoEpilation System Radiancy (Israel) Ltd. K020856 SpaTouch Pro PhotoEpilation System Radiancy (Israel) Ltd.… | 2002 |
| * | K030897 | SkinstationSummary page 2…Presumed to be K020856 SkinTouch Radiancy (Israel) Ltd. K030897, K051671 ABC Hair Removal System Palomar Medical Technologies, Inc.… | 2003 |
| * | K051671 | Radiancy Skinstation with Modified Light Unit AddemblySummary page 2…Presumed to be K020856 SkinTouch Radiancy (Israel) Ltd. K030897, K051671 ABC Hair Removal System Palomar Medical Technologies, Inc.… | 2005 |
| * | K060839 | Abc Hair Removal System Cleared while this submission was under review Summary page 2…K030897, K051671 ABC Hair Removal System Palomar Medical Technologies, Inc. K060839 System Description: The Spectra Hair Removal System consists of the Spectra Laser and Sp… | 2006 |
What descends from it? (169)
See all 1692 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 13 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K082298 (Home Skinovations, Ltd., 2008) has gone furthest, with 168 descendants of its own.
- 1 other device also cites its predicate K032846.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The Spectra Hair Removal Laser System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053527: Spectra Hair Removal Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053527
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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