510(k) · Cleared
ClearedTAMA BEMS device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tama Research Corporation · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Jun 5, 2018 as substantially equivalent to K130065 (Biosonic Technologies, LLC, 2014) after a 249-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Jun 5, 2018
- Review
- 249 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011935 (2001). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 2 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 1 generation backK130065 Beautiful Image Facial Sculpting DeviceBiosonic Technologies, LLC · 2014
- This deviceK173093 TAMA BEMS deviceTama Research Corporation · 2018
- Descendant · cites it directly · 0 of its ownK251649 Sunny Plus (Sunny)ShenB Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251909 NeurotriS (SX2500); NeurotriS (SX3800)A-1 Engineering · 2025
- Descendant · cites it directly · 0 of its ownK211055 Microcurrent device (Model: HBR2-1)Shenzhen DJ Medical Equipment Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −2 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −1 | K130065 | Beautiful Image Facial Sculpting Device | Biosonic Technologies, LLC | 2014 | — |
| 0 (this device) | K173093 | TAMA BEMS device | Tama Research Corporation | 2018 | — |
| +1 | K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd. | 2025 | — |
| +1 | K251909 | NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering | 2025 | — |
| +1 | K211055 | Microcurrent device (Model: HBR2-1) | Shenzhen DJ Medical Equipment Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 2 | 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 NFO? 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 NFO device
- #1 K233010 Beagank 4T Plusscore 28.6 · 5 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 |
|---|---|---|---|
| * | K130065 | Beautiful Image Facial Sculpting DeviceSummary page 4…Biosonic Technologies, LLC Predicate Trade Name: Beautiful Image Model 900 Facial Toning Device Predicate 510(k): K130065 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The TAMA BEMS Device is a microcurrent stimulator p… | 2014 |
What descends from it? (3)
3 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 17 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K251649 (ShenB Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K130065.
How does its category compare?
All NFO devicesNFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NFO
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFO
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFO
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFO
4in 2025
MAUDE reports naming product code NFO, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 550 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 394 | 0 | 1 |
| 2012 | 3 | 160 | 2 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 7 | 189 | 0 | 0 |
| 2018 | 5 | 177 | 0 | 0 |
| 2019 | 3 | 149 | 0 | 1 |
| 2020 | 2 | — | 0 | 6 |
| 2021 | 7 | 210 | 0 | 6 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 8 | 128 | 0 | 1 |
| 2024 | 5 | 109 | 0 | 4 |
| 2025 | 16 | 124 | 0 | 4 |
| 2026 | 8 | 153 | 0 | — |
What is it indicated for?
The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173093: TAMA BEMS device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173093
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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