510(k) · Cleared
ClearedShaser HRS2 RX 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 Sep 30, 2013 as substantially equivalent to K120080 (Shaser, Inc., 2012) and 2 other predicates after a 70-day review. Its family tree reaches back 13 generations to 1995. 97 later devices descend from it.
- Decided
- Sep 30, 2013
- Review
- 70 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K950019 (1995). 43 ancestors in all, the oldest K892514 (1990). 97 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 9 generations between
- 3 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 2 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 1 generation backK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- This deviceK132266 Shaser HRS2 RX Hair Removal SystemShaser, Inc. · 2013
- Descendant · cites it directly · 96 of its ownK133201 Shaser V-Mini 2 Hair Removal SystemShaser, Inc. · 2014
- Descendant · 2 generations on · 95 of its ownK140631 Lumena FH Hair Removal SystemShaser, Inc. · 2014
- Descendant · 3 generations on · 88 of its ownK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- Descendant · 4 generations on · 66 of its ownK192432 IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119…Shenzhen Bosidin Technology Co., Ltd. · 2019
- Descendant · 4 generations on · 26 of its ownK212318 IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022
Show all 13 generations
- Root · 13 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 12 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 11 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 10 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 9 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 8 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 7 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 6 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 5 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 4 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 3 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 2 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 1 generation backK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- This deviceK132266 Shaser HRS2 RX Hair Removal SystemShaser, Inc. · 2013
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K133201Shaser V-Mini 2 Hair Removal SystemShaser, Inc. · 2014 · cites it directly96descendants
- K140631Lumena FH Hair Removal SystemShaser, Inc. · 2014 · 2 generations on95descendants
- K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018 · 3 generations on88descendants
- K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd. · 2019 · 4 generations on66descendants
- K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022 · 4 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −12 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −11 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −10 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −9 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −8 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −7 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −6 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −5 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −4 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −3 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −2 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −1 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
| 0 (this device) | K132266 | Shaser HRS2 RX Hair Removal System | Shaser, Inc. | 2013 | — |
| +1 | K133201 | Shaser V-Mini 2 Hair Removal System | Shaser, Inc. | 2014 | — |
| +2 | K140631 | Lumena FH Hair Removal System | Shaser, Inc. | 2014 | — |
| +3 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| +4 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
| +4 | K212318 | IPL Hair Removal | Dongguan Define Beauty Electronic Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 10 | 0 |
| 2022 | 18 | 0 |
| 2023 | 21 | 0 |
| 2024 | 16 | 0 |
| 2025 | 15 | 0 |
| 2026 | 7 | 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 18.1 · 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? (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 |
|---|---|---|---|
| * | K120080 | Shaser HRS2 Hair Removal SystemSummary page 1…tion Name: Product Code ONF: Powered Light Based Non-Laser Surgical Instrument with Thermal Effect Equivalent Device: Shaiser HRS2 (K 120080), Radiancy SpaTouch (K020856), Radiance SkinStation (KOS5167 1) Device Description: Shaser HRS2 R… | 2012 |
| * | K020856 | Spatouch Photoepilation SystemSummary page 1…NF: Powered Light Based Non-Laser Surgical Instrument with Thermal Effect Equivalent Device: Shaiser HRS2 (K 120080), Radiancy SpaTouch (K020856), Radiance SkinStation (KOS5167 1) Device Description: Shaser HRS2 RX is an IPL device with a wav… | 2002 |
| * | K051671 | Radiancy Skinstation with Modified Light Unit Addembly | 2005 |
What descends from it? (97)
See all 971 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133201 | Shaser V-Mini 2 Hair Removal System | 2014 | 96 |
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 18 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 43 ancestors has a recall of any class.
- Of its descendants, K133201 (Shaser, Inc., 2014) has gone furthest, with 96 descendants of its own.
- 2 other devices also cite its predicate K120080.
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. 2013, 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 HRS2 RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser HRS2 RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare…
Read the full statement (141 words)
The Shaser HRS2 RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser HRS2 RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser HRS2 RX Hlair Removal System is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132266: Shaser HRS2 RX 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/K132266
Report an extraction error
Are you the manufacturer?
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