510(k) Report

510(k) · Cleared

Cleared

Beagank 4T Plus

K233010510(k) TraditionalCleared Nov 21, 202360-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Belega, Inc. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Cleared on Nov 21, 2023 as substantially equivalent to K191951 (Avazzia, Inc., 2021) after a 60-day review. Its family tree reaches back 5 generations to 2001. 10 later devices descend from it.

Decided
Nov 21, 2023
Review
60 days
Class
Class II
Product code
NFO
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K011935 (2001). 7 ancestors in all. 10 later devices descend from it, 7 citing it directly.

Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 3 descendants K191951 · Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device · Avazzia, Inc. · 2021K171588 · NuBODY Skin Toning Device · Carol Cole Company Dba Nuface · 2017K103472 · Nuface Plus · Carol Cole Company · 2011K072260 · Nuface, Model NU-4003 · Carol Cole Company · 2007K011935 · Rejuvenique Model #RJV10 · Salton, Inc. · 2001−50
  1. Root · 5 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
  2. 4 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
  3. 3 generations backK103472 Nuface PlusCarol Cole Company · 2011
  4. 2 generations backK171588 NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface · 2017
  5. 1 generation backK191951 Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. · 2021
  6. This deviceK233010 Beagank 4T PlusBelega, Inc. · 2023
  7. Descendant · cites it directly · 3 of its ownK243430 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
  8. Descendant · cites it directly · 1 of its ownK252146 Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd. · 2025
  9. Descendant · cites it directly · 1 of its ownK250227 JOVS Electric Stimulation Beauty Device (JE2)Shenzhen Qianyu Technology Co., Ltd. · 2025
  10. Descendant · cites it directly · 1 of its ownK244004 Microcurrent Facial Device (CEC101, EE0101, EEI101)Shenzhen Dachi Communication Co., Ltd. · 2025
  11. Descendant · 2 generations on · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2024: 12025: 42026: 5
2024high 5 (2026) · low 1 (2024)2026

Most influential descendants

Showing 5 of 10 · See all
  • K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd. · 2024 · cites it directly3descendants
  • K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd. · 2025 · cites it directly1descendant
  • K250227JOVS Electric Stimulation Beauty Device (JE2)Shenzhen Qianyu Technology Co., Ltd. · 2025 · cites it directly1descendant
  • K244004Microcurrent Facial Device (CEC101, EE0101, EEI101)Shenzhen Dachi Communication Co., Ltd. · 2025 · cites it directly1descendant
  • K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K011935Rejuvenique Model #RJV10Salton, Inc.2001—
−4K072260Nuface, Model NU-4003Carol Cole Company2007—
−3K103472Nuface PlusCarol Cole Company2011—
−2K171588NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface2017—
−1K191951Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc.2021—
0 (this device)K233010Beagank 4T PlusBelega, Inc.2023—
+1K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.2024—
+1K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.2025—
+1K250227JOVS Electric Stimulation Beauty Device (JE2)Shenzhen Qianyu Technology Co., Ltd.2025—
+1K244004Microcurrent Facial Device (CEC101, EE0101, EEI101)Shenzhen Dachi Communication Co., Ltd.2025—
+2K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202540
202650
FIG. 1 — Lineage of K233010, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221443 PureLift Pro Plusscore 22.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K191951Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
Summary page 5
…ator for Pain Relief Product Code: NFO Regulatory Standard 21 CFR 882.5890 Predicate Device: 510(k) Number: K191951 Manufacturer: Avazzia, Inc. Trade Name: Avazzia OTC TENS for Aestheti…
Avazzia, Inc.2021—
†K011935Rejuvenique Model #RJV10Salton, Inc.2001—
†K181008NuFACE TrinityCarol Cole Company Dba Nuface2018—

Also cleared against K191951: 1 other device →

What descends from it? (10)

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243
K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251
K250227JOVS Electric Stimulation Beauty Device (JE2)Shenzhen Qianyu Technology Co., Ltd.20251
K244004Microcurrent Facial Device (CEC101, EE0101, EEI101)Shenzhen Dachi Communication Co., Ltd.20251
K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20260
K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260
K252553Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15…Shenzhen Jianchao Intelligent Technology Co., Ltd.20250

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 22 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K243430 (Shenzhen Aozemei Technology Co., Ltd., 2024) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K191951.

How does its category compare?

All NFO devices

NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · NFO

16in 2025

2007: 12008: 32011: 32012: 32013: 22014: 22015: 22016: 22017: 72018: 52019: 32020: 22021: 72022: 22023: 82024: 52025: 162026 (partial year): 8
2007high 16 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NFO

124in 2025

2008: 550 days median2011: 394 days median2012: 160 days median2017: 189 days median2018: 177 days median2019: 149 days median2021: 210 days median2023: 128 days median2024: 109 days median2025: 124 days median2026 (partial year): 153 days median
2007high 550 (2008) · low 109 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NFO

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NFO

4in 2025

2011: 12013: 12015: 12016: 52019: 12020: 62021: 62022: 52023: 12024: 42025: 4
2007high 6 (2020) · low 0 (2007)2025

MAUDE reports naming product code NFO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
2008355000
20090—00
20100—00
2011339401
2012316020
20132—01
20142—00
20152—01
20162—05
2017718900
2018517700
2019314901
20202—06
2021721006
20222—05
2023812801
2024510904
20251612404
202681530—

What is it indicated for?

The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K233010: Beagank 4T Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233010

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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