510(k) · Cleared
ClearedShaser V-Mini RX
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 Nov 26, 2013 as substantially equivalent to K130015 (Shaser, Inc., 2013) and 2 other predicates after a 134-day review. Its family tree reaches back 1 generation to 2002. 23 later devices descend from it.
- Decided
- Nov 26, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K020856 (2002). 3 ancestors in all. 23 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020856 Spatouch Photoepilation SystemRadiancy (Israel), Ltd. · 2002
- This deviceK132170 Shaser V-Mini RXShaser, Inc. · 2013
- Descendant · cites it directly · 22 of its ownK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
- Descendant · cites it directly · 15 of its ownK213558 IPL Hair Removal DeviceUlike Co., Ltd. · 2022
- Descendant · 2 generations on · 14 of its ownK212907 Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021
- Descendant · 2 generations on · 12 of its ownK221214 Hand-held IPL device (IPL Home Use Hair Removal Device)…Shenzhen Ionka Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 11 of its ownK230739 Hand-held IPL device (IPL Home Use Hair Removal Device), Model…Shenzhen Ionka Medical Technology Co., Ltd. · 2023
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019 · cites it directly22descendants
- K213558IPL Hair Removal DeviceUlike Co., Ltd. · 2022 · cites it directly15descendants
- K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021 · 2 generations on14descendants
- K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2022 · 2 generations on12descendants
- K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2023 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020856 | Spatouch Photoepilation System | Radiancy (Israel), Ltd. | 2002 | — |
| 0 (this device) | K132170 | Shaser V-Mini RX | Shaser, Inc. | 2013 | — |
| +1 | K190820 | Aimanfun Lumea Comfort | Kam Yuen Plastic Products, Ltd. | 2019 | — |
| +1 | K213558 | IPL Hair Removal Device | Ulike Co., Ltd. | 2022 | — |
| +2 | K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products, Ltd. | 2021 | — |
| +2 | K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G… | Shenzhen Ionka Medical Technology Co., Ltd. | 2022 | — |
| +3 | K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608… | Shenzhen Ionka Medical Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 18.2 · 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 |
|---|---|---|---|
| * | K130015 | Shaser V-Mini Hair Removal SystemSummary page 1…ssification Name: Product Code ONE: Powered Light Based Non-Laser Surgical Instrument with Thermnal Effect Equivalent Device: Shaser V-MINI (K130015), Radiancy SpaTouch (K020856), Radiance SkinStation (KOS51671) Device Description: Shaser V-MINI RN is… | 2013 |
| * | K020856 | Spatouch Photoepilation SystemSummary page 1…ode ONE: Powered Light Based Non-Laser Surgical Instrument with Thermnal Effect Equivalent Device: Shaser V-MINI (K130015), Radiancy SpaTouch (K020856), Radiance SkinStation (KOS51671) Device Description: Shaser V-MINI RN is an IPL device with a waveleng… | 2002 |
| * | K051671 | Radiancy Skinstation with Modified Light Unit Addembly | 2005 |
What descends from it? (23)
See all 232 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?
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 V-MINI 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 V-MINI 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 (140 words)
The Shaser V-MINI 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 V-MINI 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- VI. The Shaser V-MINI RX Hair 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/K132170 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132170: Shaser V-Mini RX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132170
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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