510(k) · Cleared
ClearedLumena FH 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 16, 2014 as substantially equivalent to K133201 (Shaser, Inc., 2014) after a 65-day review. Its family tree reaches back 15 generations to 1995. 95 later devices descend from it.
- Decided
- May 16, 2014
- Review
- 65 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K950019 (1995). 46 ancestors in all, the oldest K892514 (1990). 95 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 11 generations between
- 3 generations backK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- 2 generations backK132266 Shaser HRS2 RX Hair Removal SystemShaser, Inc. · 2013
- 1 generation backK133201 Shaser V-Mini 2 Hair Removal SystemShaser, Inc. · 2014
- This deviceK140631 Lumena FH Hair Removal SystemShaser, Inc. · 2014
- Descendant · cites it directly · 88 of its ownK181568 IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018
- Descendant · 2 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 · 2 generations on · 26 of its ownK212318 IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 25 of its ownK221002 IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd. · 2022
- Descendant · 3 generations on · 24 of its ownK210311 Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B…Shenzhen Mismon Technology Co., Ltd. · 2021
Show all 15 generations
- Root · 15 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 14 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- 13 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- 12 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- 11 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
- 10 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
- 9 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
- 8 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
- 7 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
- 6 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
- 5 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
- 4 generations backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
- 3 generations backK120080 Shaser HRS2 Hair Removal SystemShaser, Inc. · 2012
- 2 generations backK132266 Shaser HRS2 RX Hair Removal SystemShaser, Inc. · 2013
- 1 generation backK133201 Shaser V-Mini 2 Hair Removal SystemShaser, Inc. · 2014
- This deviceK140631 Lumena FH Hair Removal SystemShaser, Inc. · 2014
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K181568IPL Salon Hair Reduction SystemMedical Device Branch of Zhangzhou Easepal Industrial Co.,Lt · 2018 · cites it directly88descendants
- K192432IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130Shenzhen Bosidin Technology Co., Ltd. · 2019 · 2 generations on66descendants
- K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd. · 2022 · 2 generations on26descendants
- K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd. · 2022 · 3 generations on25descendants
- K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd. · 2021 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −14 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| −13 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| −12 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| −11 | K011747 | Palomar LC 100 Diode Laser | Palomar Medical Technologies, Inc. | 2001 | — |
| −10 | K032846 | Spectra Pulsed Diode Laser, Model DR-1 | Spectragenics, Inc. | 2003 | — |
| −9 | K052848 | Spectra Hair Removal Laser | Spectragenics, Inc. | 2005 | — |
| −8 | K060839 | Abc Hair Removal System | Palomar Medical Technologies, Inc. | 2006 | — |
| −7 | K072906 | SILK'N | Home Skinovations, Ltd. | 2008 | — |
| −6 | K082298 | Flash N' GO | Home Skinovations, Ltd. | 2008 | — |
| −5 | K090820 | Tria Hair Removal Laser System | Spectragenics, Inc. | 2009 | — |
| −4 | K103184 | Silk'n Flash N GO | Home Skinovations, Ltd. | 2010 | — |
| −3 | K120080 | Shaser HRS2 Hair Removal System | Shaser, Inc. | 2012 | — |
| −2 | K132266 | Shaser HRS2 RX Hair Removal System | Shaser, Inc. | 2013 | — |
| −1 | K133201 | Shaser V-Mini 2 Hair Removal System | Shaser, Inc. | 2014 | — |
| 0 (this device) | K140631 | Lumena FH Hair Removal System | Shaser, Inc. | 2014 | — |
| +1 | K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | 2018 | — |
| +2 | K192432 | IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129… | Shenzhen Bosidin Technology Co., Ltd. | 2019 | — |
| +2 | K212318 | IPL Hair Removal | Dongguan Define Beauty Electronic Technology Co., Ltd. | 2022 | — |
| +3 | K221002 | IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C | Shenzhen Ulike Smart Electronics Co., Ltd. | 2022 | — |
| +3 | K210311 | Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B… | Shenzhen Mismon Technology Co., Ltd. | 2021 | — |
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 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K133201 | Shaser V-Mini 2 Hair Removal SystemSummary page 2…Exhibit ES- (1 of 3) Proposed Modified Device Predicate Device 510(k) K133201 Manufacturer Shaser. Inc. Shaser. Inc. Trade Na… | 2014 |
What descends from it? (95)
See all 953 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 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 46 ancestors has a recall of any class.
- Of its descendants, K181568 (Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt, 2018) has gone furthest, with 88 descendants of its own.
- 1 other device also cites its predicate K133201.
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. 2014, 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?
Lumena PH is an over the counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothennal treatment. It is also indicated for the removal of unwanted body nd/or facial hair In adults with Fitzpatrick skin types I - IV. The Lumena FH is also Intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction inthe 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/K140631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140631: Lumena FH 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/K140631
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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