510(k) · Cleared
ClearedFACEGYM Pro Device (HD-109)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical Equipment Co., Ltd. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Jul 23, 2026 as substantially equivalent to K221443 (Xtreem Pulse, LLC, 2022) and 1 other predicate after a 226-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jul 23, 2026
- Review
- 226 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K011935 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 6 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 5 generations backK103472 Nuface PlusCarol Cole Company · 2011
- 4 generations backK171588 NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface · 2017
- 3 generations backK191951 Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. · 2021
- 2 generations backK233010 Beagank 4T PlusBelega, Inc. · 2023
- 1 generation backK250227 JOVS Electric Stimulation Beauty Device (JE2)Shenzhen Qianyu Technology Co., Ltd. · 2025
- This deviceK253932 FACEGYM Pro Device (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −6 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −5 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| −4 | K171588 | NuBODY Skin Toning Device | Carol Cole Company Dba Nuface | 2017 | — |
| −3 | K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device | Avazzia, Inc. | 2021 | — |
| −2 | K233010 | Beagank 4T Plus | Belega, Inc. | 2023 | — |
| −1 | K250227 | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | 2025 | — |
| 0 (this device) | K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K221443 | PureLift Pro PlusSummary page 5…Aesthetic Purposes Review Panel: Neurology Product Code: NFO Regulation Number: 21 CFR 882.5890 Regulation Class: II 3. Predicate Device Information Predicate Device 1: K221443 Sponsor: XTREEM PULSE LLC Trade Name: PureLift Pro Plus) Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Pu… | 2022 |
| * | K250227 | JOVS Electric Stimulation Beauty Device (JE2)Summary page 5…tor, Transcutaneous Electrical, Aesthetic Purposes Review Panel: Neurology Product Code: NFO Regulation Number: 21 CFR 882.5890 Regulation Class: II Predicate Device 2: K250227 Sponsor: Shenzhen Qianyu Technology Co., Ltd. Trade Name: JOVS Electric Stimulation Beauty Device (JE2) Classification Name: Stim… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 7 companies; a new generation was cleared every 3.7 years on median.
- None of the 12 ancestors has a recall.
- 5 other devices also cite its predicate K221443.
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. 2026, 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 FACEGYM Pro Device (Model: HD-109) is intended for facial and neck stimulation and is indicated for
over-the-counter cosmetic use.
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/K253932 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253932: FACEGYM Pro Device (HD-109).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253932
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026