510(k) · Cleared
ClearedShaser V-Mini 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 Jun 13, 2013 after a 161-day review. The FDA summary names its predicate without a number. 111 later devices descend from it.
- Decided
- Jun 13, 2013
- Review
- 161 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 0
111 later devices descend from it, 2 citing it directly.
- This deviceK130015 Shaser V-Mini 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
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 111 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K130015 | Shaser V-Mini 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 13 | 0 |
| 2022 | 21 | 0 |
| 2023 | 23 | 0 |
| 2024 | 17 | 0 |
| 2025 | 17 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | — | Shaser HRS2 Hair Removal System Named without a submission number |
What descends from it? (111)
See all 1112 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?
- Of its descendants, K133201 (Shaser, Inc., 2014) has gone furthest, with 96 descendants of its own.
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 HRS3 hair removal system is an over the counter device intended for removal of unwanted hair. It 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130015: Shaser V-Mini 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/K130015
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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