510(k) · Cleared

Cleared

The Buzz Facial Toning System

K102494510(k) TraditionalCleared Dec 9, 2011465-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

Daka International, Ltd. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Cleared on Dec 9, 2011 as substantially equivalent to K011935 (Salton, Inc., 2001) and 5 other predicates after a 465-day review. Its family tree reaches back 4 generations to 1996.

Decided: Dec 9, 2011
Review: 465 days
Class: Class II
Product code: NFO
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K951951 (1996). 10 ancestors in all, the oldest K870947 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK951951 Focus Model 795 UnitEmpi · 1996
3 generations backK041575 Fenzian Treatment SystemEumedic Limited · 2004
2 generations backK042912 INTERX5000Neuro Resource Group, Inc. · 2005 · Recalled
1 generation backK070217 Interx 1000/Derma 200 Stimulator for Cosmetic UseNeuro Resource Group, Inc. · 2008
This deviceK102494 The Buzz Facial Toning SystemDaka International, Ltd. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K951951	Focus Model 795 Unit	Empi	1996	—
−3	K041575	Fenzian Treatment System	Eumedic Limited	2004	—
−2	K042912	INTERX5000	Neuro Resource Group, Inc.	2005	1
−1	K070217	Interx 1000/Derma 200 Stimulator for Cosmetic Use	Neuro Resource Group, Inc.	2008	—
0 (this device)	K102494	The Buzz Facial Toning System	Daka International, Ltd.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
2001	1	0
2005	1	0
2007	1	0
2008	2	0

FIG. 1 — Lineage of K102494, 1996–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K011935	Rejuvenique Model #RJV10 Summary page 1 …ial Toning System Classification Name: TENS Device for aesthetic use. Classification Code: NFO, Class Il Indications: Indicated for cosmetic use. 3. Predicate Devices K011935 —Salton Inc- Rejuvenique K040871-FaceMaster of Beverly Hills- Facemaster KQ72260-Carol Cole Company- Nuface K070217 —Neuro Resou…	Salton, Inc.	2001	—
*	K040871	Facemaster Facial Toning System Summary page 1 …Name: TENS Device for aesthetic use. Classification Code: NFO, Class Il Indications: Indicated for cosmetic use. 3. Predicate Devices K011935 —Salton Inc- Rejuvenique K040871-FaceMaster of Beverly Hills- Facemaster KQ72260-Carol Cole Company- Nuface K070217 —Neuro Resource Group-Interx 1000 K070250- Is…	Facemaster of Beverly Hills, Inc.	2005	—
*	K072260	Nuface, Model NU-4003	Carol Cole Company	2007	—
*	K070217	Interx 1000/Derma 200 Stimulator for Cosmetic Use Summary page 1 …: Indicated for cosmetic use. 3. Predicate Devices K011935 —Salton Inc- Rejuvenique K040871-FaceMaster of Beverly Hills- Facemaster KQ72260-Carol Cole Company- Nuface K070217 —Neuro Resource Group-Interx 1000 K070250- Isomers Lab-Nutritone Facial System K071573- Fatrotek SRL- Rugalift Please see attach…	Neuro Resource Group, Inc.	2008	—
*	K070250	Nutritone Facial Beauty System Summary page 1 …e Devices K011935 —Salton Inc- Rejuvenique K040871-FaceMaster of Beverly Hills- Facemaster KQ72260-Carol Cole Company- Nuface K070217 —Neuro Resource Group-Interx 1000 K070250- Isomers Lab-Nutritone Facial System K071573- Fatrotek SRL- Rugalift Please see attached Predicate Chart "0 oTe…	Isomers Laboratories, Inc.	2008	—
*	K071573	Rugalift, Model# V.2.1 Summary page 1 …040871-FaceMaster of Beverly Hills- Facemaster KQ72260-Carol Cole Company- Nuface K070217 —Neuro Resource Group-Interx 1000 K070250- Isomers Lab-Nutritone Facial System K071573- Fatrotek SRL- Rugalift Please see attached Predicate Chart "0 oTe A 4. Device Description The Buzz Facial To…	Fatrotek S.R.L.	2008	—
†	K022006	Conductive Gel	The Dezac Group	2002	—

Also cleared against K011935: 5 other devices →

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 15 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
1 of the 10 ancestors has a recall of any class.
5 other devices also cite its predicate K011935.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · NFO

16in 2025

2007high 16 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NFO

124in 2025

2007high 550 (2008) · low 109 (2024)2026

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

Recalls per year · NFO

2in 2012

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

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

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 Beauty Buzz Facial Toning System is indicated for 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/K102494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102494: The Buzz Facial Toning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102494

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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