510(k) · Cleared
ClearedAbc Hair Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Technologies, Inc. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Dec 7, 2006 as substantially equivalent to K020856 (Radiancy (Israel), Ltd., 2002) and 2 other predicates after a 254-day review. Its family tree reaches back 7 generations to 1995. 171 later devices descend from it.
- Decided
- Dec 7, 2006
- Review
- 254 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K950019 (1995). 21 ancestors in all. 171 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 6 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 5 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 4 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 3 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 2 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 1 generation backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- This deviceK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 169 of its ownK053527 Spectra Hair Removal LaserSpectragenics, Inc. · 2008
- Descendant · cites it directly · 169 of its ownK072906 SILK'NHome Skinovations, Ltd. · 2008
- Descendant · cites it directly · 168 of its ownK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- Descendant · 2 generations on · 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
Showing 5 of 171 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 171 · See all- K053527Spectra Hair Removal LaserSpectragenics, Inc. · 2008 · cites it directly169descendants
- K072906SILK'NHome Skinovations, Ltd. · 2008 · cites it directly169descendants
- K082298Flash N' GOHome Skinovations, Ltd. · 2008 · cites it directly168descendants
- K090820Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009 · 2 generations on167descendants
- K103184Silk'n Flash N GOHome Skinovations, Ltd. · 2010 · 2 generations on148descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −6 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −5 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −4 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −3 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −2 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −1 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| 0 (this device) | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| +1 | K053527 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2008 | — |
| +1 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| +1 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| +2 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| +2 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 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 OHT? 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 OHT device
- #1 K221002 IPL Hair Removal Device, Model (s): UI04A…score 36.1 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K020856 | Spatouch Photoepilation SystemSummary page 1…matology (21 CFR §878.4810) PRODUCT CODE: GEX 3. PREDICATE DEVICES SpaTouch® PhotoEpilation System (K020856) Radiancy (Israel) Ltd. Spectra Hair Removal Laser (K052848) SpectraGenics, Inc. Palomar SLPTM 1000 (K0… | 2002 |
| * | K052848 | Spectra Hair Removal LaserSummary page 1…ODUCT CODE: GEX 3. PREDICATE DEVICES SpaTouch® PhotoEpilation System (K020856) Radiancy (Israel) Ltd. Spectra Hair Removal Laser (K052848) SpectraGenics, Inc. Palomar SLPTM 1000 (K013028) Palomar Medical Technologies, Inc. PALOMAR MEDICAL TECHNOLO… | 2005 |
| * | K013028 | Palomar SLP 1000Summary page 1…SpaTouch® PhotoEpilation System (K020856) Radiancy (Israel) Ltd. Spectra Hair Removal Laser (K052848) SpectraGenics, Inc. Palomar SLPTM 1000 (K013028) Palomar Medical Technologies, Inc. PALOMAR MEDICAL TECHNOLOGIES, INC. PAGE 1 OF 2… | 2001 |
What descends from it? (171)
See all 1713 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 11 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K053527 (Spectragenics, Inc., 2008) has gone furthest, with 169 descendants of its own.
- 8 other devices also cite its predicate K020856.
How does its category compare?
All OHT devicesOHT Light Based Over-The-Counter Hair Removal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OHT
25in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHT
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHT
No recall names OHT since 2007.
Adverse event reports per year · OHT
6in 2025
MAUDE reports naming product code OHT, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 81 | 0 | 2 |
| 2017 | 6 | 87 | 0 | 0 |
| 2018 | 8 | 89 | 0 | 0 |
| 2019 | 7 | 64 | 0 | 2 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 12 | 89 | 0 | 1 |
| 2022 | 25 | 70 | 0 | 2 |
| 2023 | 32 | 83 | 0 | 6 |
| 2024 | 26 | 62 | 0 | 0 |
| 2025 | 25 | 87 | 0 | 6 |
| 2026 | 11 | 84 | 0 | — |
What is it indicated for?
The ABC Hair Removal 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/K060839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060839: Abc Hair Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060839
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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