510(k) · Cleared
ClearedShaser Ipl Hair Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shaser, Inc. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on May 18, 2011 as substantially equivalent to K082298 (Home Skinovations, Ltd., 2008) and 1 other predicate after a 166-day review. Its family tree reaches back 11 generations to 1995. 140 later devices descend from it.
- Decided
- May 18, 2011
- Review
- 166 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K950019 (1995). 28 ancestors in all. 140 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 7 generations between
- 3 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 2 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 1 generation backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- This deviceK103560 Shaser Ipl Hair Removal SystemShaser, Inc. · 2011
- Descendant · cites it directly · 135 of its ownK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- Descendant · cites it directly · 127 of its ownK121598 ME HAIR2GOSyneron Medical, Ltd. · 2012
- Descendant · 2 generations on · 126 of its ownK123845 MESyneron Beauty, Ltd. · 2013
- Descendant · cites it directly · 125 of its ownK131649 MESyneron Beauty, Ltd. · 2013
- Descendant · cites it directly · 125 of its ownK122280 Ipulse Smoothskin Hair Removal SystemCyden Limited · 2012
Show all 11 generations
- Root · 11 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 10 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 9 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 8 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 7 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 6 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 5 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 4 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 3 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 2 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 1 generation backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- This deviceK103560 Shaser Ipl Hair Removal SystemShaser, Inc. · 2011
Showing 5 of 140 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 140 · See all- K120080Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012 · cites it directly135descendants
- K121598ME HAIR2GOSyneron Medical, Ltd. · 2012 · cites it directly127descendants
- K123845MESyneron Beauty, Ltd. · 2013 · 2 generations on126descendants
- K131649MESyneron Beauty, Ltd. · 2013 · cites it directly125descendants
- K122280Ipulse Smoothskin Hair Removal SystemCyden Limited · 2012 · cites it directly125descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −10 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −9 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −8 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −7 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −6 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −5 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −4 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −3 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −2 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −1 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| 0 (this device) | K103560 | Shaser Ipl Hair Removal System | Shaser, Inc. | 2011 | — |
| +1 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
| +1 | K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012 | — |
| +2 | K123845 | ME | Syneron Beauty, Ltd. | 2013 | — |
| +1 | K131649 | ME | Syneron Beauty, Ltd. | 2013 | — |
| +1 | K122280 | Ipulse Smoothskin Hair Removal System | Cyden Limited | 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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2021 | 14 | 0 |
| 2022 | 23 | 0 |
| 2023 | 28 | 0 |
| 2024 | 20 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.2 · 27 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 |
|---|---|---|---|
| * | K082298 | Flash N' GOSummary page 1…Technological Characteristics and Comparison to Predicate Device(s): The SHASER IL Hair Removal System is substantially equivalent to the Home Skinovations Flash N' Go, K082298, and the Tria Beauty Tria Laser Hair Removal System, K090820. The SHASER IPL Hair Removal System has the same intended uses and… | 2008 |
| * | K090820 | Tria Hair Removal Laser SystemSummary page 1…duct code GEX Predicate device: Home Skinovations Flash N' Go, K(082298 Tria Beauty Tria Laser Hair Removal System, K090820 Reason for submission: Not previously marketed in the USA Device Description: The SHASER IL Hair Removal System is… | 2009 |
What descends from it? (140)
See all 1405 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 16 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K120080 (Shaser, Inc., 2012) has gone furthest, with 135 descendants of its own.
- 5 other devices also cite its predicate K082298.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SHASER IPL Hair Removal System is an over the counter device intended for removal of unwanted hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103560 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103560: Shaser Ipl Hair Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103560
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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