510(k) · Cleared
ClearedHandheld Diode Laser for Hair Removal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liaoning Sidey Optoelectronics Technologies Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Feb 8, 2017 as substantially equivalent to K120737 (Tria Beauty, Inc., 2012) and 1 other predicate after an 86-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Feb 8, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K950019 (1995). 30 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK163173 Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd. · 2017
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 deviceK163173 Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd. · 2017
View 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) | K163173 | Handheld Diode Laser for Hair Removal | Liaoning Sidey Optoelectronics Technologies Co., Ltd. | 2017 | — |
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 |
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K120737 | Tria Laser Hair Removal SystemSummary page 6…7‐2 510(k) Summary 6. Identification of Predicate Device Predicate 1#: 510(k) Number: K120737 Product Name: TRIA Laser Hair Removal System Manufacturer: Tria Beauty, Inc. Predicate 2#: 510(k) Number: K… | 2012 |
| * | K142845 | SILKPRO laser hair removal systemSummary page 6…Predicate 1#: 510(k) Number: K120737 Product Name: TRIA Laser Hair Removal System Manufacturer: Tria Beauty, Inc. Predicate 2#: 510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Company, Ltd. 7. Non-Clinic… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 ancestors has a recall of any class.
- 3 other devices also cite its predicate K120737.
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. 2017, this device’s year, is highlighted.
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 Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal 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/K163173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163173: Handheld Diode Laser for Hair Removal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163173
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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